SENATE BILL NO. 272 February 4, 1999, Introduced by Senators HOFFMAN, BENNETT, DUNASKISS, STILLE, SIKKEMA, BYRUM, GAST, DE BEAUSSAERT, A. SMITH and EMMONS and referred to the Committee on Natural Resources and Environmental Affairs. A bill to amend 1994 PA 451, entitled "Natural resources and environmental protection act," (MCL 324.101 to 324.90106) by adding part 205. THE PEOPLE OF THE STATE OF MICHIGAN ENACT: 1 PART 205 LABORATORY ACCREDITATION 2 SEC. 20501. AS USED IN THIS PART: 3 (A) "ACCREDITATION" MEANS THE PROCESS BY WHICH THE DEPART- 4 MENT RECOGNIZES A LABORATORY AS MEETING QUALIFICATIONS OR STAN- 5 DARDS UNDER THIS PART OR IN RULES PROMULGATED UNDER THIS PART. 6 (B) "ACCREDITED LABORATORY" OR "ACCREDITED" MEANS OR REFERS 7 TO A LABORATORY THAT IS IN COMPLIANCE WITH THE ACCREDITATION 8 REQUIREMENTS OF THIS PART. 9 (C) "ANALYTE" MEANS THE SUBSTANCE OR PHYSICAL PROPERTY 10 CONTAINED IN A SAMPLE FOR WHICH ANALYSIS IS PERFORMED. 00084'99 TMV 2 1 (D) "ANALYTICAL DATA" MEANS THE QUALITATIVE OR QUANTITATIVE 2 MEASURES REPORTED TO A STATE OR FEDERAL AGENCY AS THE RESULT OF 3 CHEMICAL, PHYSICAL, BIOLOGICAL, MICROBIOLOGICAL, RADIOLOGICAL, OR 4 OTHER SCIENTIFIC DETERMINATION. 5 (E) "APPLICANT" MEANS A LABORATORY APPLYING TO THE DEPART- 6 MENT TO BECOME AN ACCREDITED LABORATORY. 7 (F) "CERTIFICATION OF COMPLIANCE STATEMENT" MEANS A STATE- 8 MENT REQUIRED WITH THE APPLICATION FOR ACCREDITATION, SIGNED AND 9 DATED BY THE APPLICANT, ACKNOWLEDGING THAT THE LABORATORY IS 10 REQUIRED TO BE CONTINUALLY IN COMPLIANCE WITH THIS PART. 11 (G) "COMMERCIAL LABORATORY" MEANS A LABORATORY THAT ANALYZES 12 ENVIRONMENTAL SAMPLES FOR A FEE. 13 (H) "CONSUMER PRICE INDEX" MEANS THE ANNUAL AVERAGE PERCEN- 14 TAGE INCREASE IN THE DETROIT CONSUMER PRICE INDEX FOR ALL ITEMS 15 AS REPORTED BY THE UNITED STATES DEPARTMENT OF LABOR. 16 (I) "DEPARTMENT" MEANS THE DEPARTMENT OF ENVIRONMENTAL 17 QUALITY. 18 (J) "DOUBLE BLIND PROFICIENCY TESTING SAMPLE" MEANS A PROFI- 19 CIENCY TESTING SAMPLE SUBMITTED TO A LABORATORY AS A REGULAR 20 SAMPLE AND NOT IDENTIFIED AS A PROFICIENCY TESTING SAMPLE. 21 (K) "LABORATORY" MEANS A LABORATORY THAT ANALYZES ENVIRON- 22 MENTAL SAMPLES FOR MONITORING OR COMPLIANCE WITH STATE ENVIRON- 23 MENTAL LAW. LABORATORY FACILITIES HOUSED IN 2 OR MORE BUILDINGS 24 ARE A SINGLE LABORATORY IF THOSE BUILDINGS ARE AT THE SAME 25 LOCATION. 26 (l) "LABORATORY DIRECTOR" MEANS THE INDIVIDUAL EMPLOYED BY A 27 LABORATORY WHO HAS ULTIMATE RESPONSIBILITY FOR LABORATORY 00084'99 3 1 OPERATIONS, INCLUDING BUT NOT LIMITED TO QUALITY CONTROL, RESULT 2 REPORTING, PERSONNEL CONTROL, AND SIGNATURE AUTHORITY FOR THE 3 VALIDATION STATEMENT SUPPLIED WITH EACH SET OF LABORATORY 4 RESULTS. LABORATORY DIRECTOR INCLUDES A QUALIFIED INDIVIDUAL 5 DESIGNATED BY THE LABORATORY DIRECTOR AS HIS OR HER 6 REPRESENTATIVE. 7 (M) "ON-SITE ASSESSMENT CONTRACTOR" MEANS A PERSON UNDER 8 CONTRACT TO THE DEPARTMENT FOR THE PURPOSE OF PERFORMING ON-SITE 9 ASSESSMENT OF LABORATORIES TO EVALUATE COMPLIANCE WITH THIS 10 PART. 11 (N) "PARAMETER" MEANS A SINGLE DETERMINATION OR GROUP OF 12 RELATED DETERMINATIONS USING A SPECIFIC WRITTEN METHOD. 13 (O) "PERSON" MEANS AN INDIVIDUAL, PARTNERSHIP, CORPORATION, 14 ASSOCIATION, OR OTHER LEGAL ENTITY. 15 (P) "PT" MEANS PROFICIENCY TESTING, WHICH IS TESTING TO 16 DETERMINE WHETHER THE LABORATORY CAN PRODUCE ANALYTICAL RESULTS 17 WITHIN SPECIFIED PERFORMANCE LIMITS. 18 (Q) "PT PROGRAM" MEANS A GOVERNMENT ENTITY OR A PRIVATE 19 ENTITY UNDER CONTRACT TO OR OTHERWISE APPROVED BY THE DEPARTMENT 20 THAT PROVIDES RIGOROUSLY CONTROLLED AND STANDARDIZED PT SAMPLES. 21 (R) "PT SAMPLE" MEANS A SAMPLE, THE COMPOSITION OF WHICH IS 22 UNKNOWN TO THE LABORATORY PERFORMING THE ANALYSIS AND IS PROVIDED 23 FOR PT. 24 (S) "QUALITY ASSURANCE" MEANS AN INTEGRATED SYSTEM OF ACTIV- 25 ITIES INVOLVING PLANNING, QUALITY CONTROL, QUALITY ASSESSMENT, 26 REPORTING, AND QUALITY IMPROVEMENT TO ENSURE THAT ANALYTICAL 27 SERVICES MEET DEFINED STANDARDS OF QUALITY. 00084'99 4 1 (T) "QUALITY ASSURANCE PLAN" MEANS A WRITTEN DESCRIPTION OF 2 THE LABORATORY'S QUALITY ASSURANCE AND ALL ASSOCIATED 3 ACTIVITIES. 4 (U) "QUALITY CONTROL" MEANS THE SYSTEM OF TECHNICAL ACTIVI- 5 TIES, THE PURPOSE OF WHICH IS TO MEASURE AND CONTROL THE QUALITY 6 OF ANALYTICAL SERVICES SO THAT SPECIFIC PERFORMANCE CRITERIA ARE 7 MET. 8 (V) "RAW DATA" MEANS THE QUALITATIVE OR QUANTITATIVE MEA- 9 SUREMENTS RECORDED FROM CHEMICAL, PHYSICAL, BIOLOGICAL, MICROBIO- 10 LOGICAL, RADIOLOGICAL, OR OTHER SCIENTIFIC DETERMINATION, OR 11 RECORDED OBSERVATIONS AND COMMENTS RELEVANT TO THE MEASUREMENTS 12 IN UNEDITED FORM. 13 (W) "RECIPROCITY" MEANS ACCEPTANCE OF A CERTIFICATION OR 14 ACCREDITATION BETWEEN THE DEPARTMENT AND ANOTHER STATE. 15 (X) "SAMPLE" MEANS A FIELD OR LABORATORY COLLECTED SAMPLE 16 AND ANY PORTION OF THIS SAMPLE IN THE ANALYTICAL PROCESS INCLUD- 17 ING A SUBSAMPLE, ALIQUOT, EXTRACT, OR DIGESTATE. 18 (Y) "STATE AGENCY" MEANS THE STATE GOVERNMENT OF ANY STATE 19 OF THE UNITED STATES OF AMERICA. 20 (Z) "VALIDATION STATEMENT" MEANS A STATEMENT THAT IS PRO- 21 VIDED WITH EACH SET OF RESULTS SIGNED BY THE LABORATORY DIRECTOR 22 INDICATING THAT ALL OF THE REQUIREMENTS OF THIS PART AND RULES 23 PROMULGATED UNDER THIS PART HAVE BEEN MET RELATIVE TO ALL ANALYT- 24 ICAL STEPS AND QUALITY CONTROL ASSOCIATED WITH A SET OF LABORA- 25 TORY RESULTS. 26 SEC. 20502. (1) BY RULES PROMULGATED UNDER THIS PART, THE 27 DEPARTMENT MAY REQUIRE THAT ANALYTICAL DATA REQUIRED UNDER THIS 00084'99 5 1 ACT AND SUBMITTED TO THE DEPARTMENT FOR ENVIRONMENTAL REGULATORY 2 MONITORING OR COMPLIANCE PURPOSES BE PRODUCED OR DEVELOPED BY A 3 LABORATORY ACCREDITED BY THE DEPARTMENT UNDER THIS PART FOR THE 4 CATEGORIES, PARAMETERS, ANALYTES, OR METHODS FOR WHICH THE ANA- 5 LYTICAL DATA ARE SUBMITTED. 6 (2) ANY RULES REFERRED TO IN SUBSECTION (1) SHALL ALSO 7 REQUIRE ACCREDITATION OF A LABORATORY OPERATED BY THE DEPARTMENT 8 FOR ENVIRONMENTAL REGULATORY MONITORING OR COMPLIANCE PURPOSES. 9 (3) THIS PART DOES NOT PROHIBIT OTHER STATE CERTIFICATION, 10 ACCREDITATION, LICENSING, OR REGISTRATION PROGRAMS ESTABLISHED 11 BEFORE THE EFFECTIVE DATE OF THIS PART. THE STATE DRINKING WATER 12 LABORATORY CERTIFICATION PROGRAM UNDER THE SAFE DRINKING WATER 13 ACT, 1976 PA 399, MCL 325.1001 TO 325.1023, IS UNAFFECTED BY THIS 14 PART UNLESS OTHERWISE PROVIDED BY RULE. 15 (4) THE DEPARTMENT MAY EXEMPT FROM SUBSECTION (1) DATA FROM 16 LABORATORIES THAT HAVE CURRENT CONTRACTS WITH THE ENVIRONMENTAL 17 PROTECTION AGENCY SUPERFUND CONTRACT LABORATORY PROGRAM IF THE 18 DATA MEET ALL OF THE FOLLOWING REQUIREMENTS: 19 (A) THE DATA ARE SUBMITTED BY THOSE LABORATORIES TO THE 20 STATE OR FEDERAL GOVERNMENT. 21 (B) THE DATA PERTAIN TO CLEANUP ACTIVITIES UNDER A SUPERFUND 22 SITE. 23 (C) THE DATA ARE CONSISTENT WITH THE ENVIRONMENTAL PROTEC- 24 TION AGENCY SUPERFUND LABORATORY CONTRACT IN EFFECT AT THE TIME 25 THE DATA ARE PRODUCED. 00084'99 6 1 (5) THE DEPARTMENT MAY ACCEPT SAMPLE RESULTS PRODUCED BY A 2 NONACCREDITED LABORATORY IF BOTH OF THE FOLLOWING REQUIREMENTS 3 ARE MET: 4 (A) A WRITTEN REQUEST FOR A VARIANCE IS SUBMITTED TO THE 5 DEPARTMENT BY THE PERSON WHO IS REQUIRED TO SUBMIT THE DATA FOR 6 REGULATORY PURPOSES EXPLAINING WHY A VARIANCE IS NECESSARY AND 7 WHY SUCH SAMPLE RESULTS WERE NOT OR COULD NOT BE PRODUCED BY AN 8 ACCREDITED LABORATORY. 9 (B) THE SAMPLE RESULTS ARE SUBMITTED WITH THE METHOD AND ALL 10 METHOD VALIDATION DATA, CALIBRATION DATA, RAW DATA, AND QUALITY 11 CONTROL DATA, OR AT THE OPTION OF THE DEPARTMENT, WITH A DATA 12 VALIDATION REPORT FROM AN ON-SITE ASSESSMENT CONTRACTOR UNDER 13 CONTRACT TO THE DEPARTMENT. 14 (6) EACH LABORATORY SHALL BE INDIVIDUALLY ACCREDITED. 15 (7) MOBILE LABORATORIES OWNED AND OPERATED BY A STATIONARY 16 LABORATORY AND UNDER THE CONTROL OF THE LABORATORY DIRECTOR OF 17 THE STATIONARY LABORATORY MAY, AT THE OPTION OF THE STATIONARY 18 LABORATORY, BE CONSIDERED PART OF THE STATIONARY LABORATORY FOR 19 PURPOSES OF GRANTING ACCREDITATION BUT ARE SEPARATE LABORATORIES 20 FOR PURPOSES OF SATISFYING THE PT TESTING, ON-SITE ASSESSMENT, 21 AND OTHER REQUIREMENTS OF ACCREDITATION. 22 (8) MOBILE LABORATORIES OWNED BY THE SAME PERSON BUT NOT 23 DESCRIBED BY SUBSECTION (7) MAY, AT THE OPTION OF THE OWNER, BE 24 CONSIDERED A SINGLE LABORATORY UNIT FOR PURPOSES OF GRANTING 25 ACCREDITATION, BUT ARE SEPARATE LABORATORIES FOR PURPOSES OF SAT- 26 ISFYING THE PT TESTING, ON-SITE ASSESSMENT, AND OTHER 27 REQUIREMENTS OF ACCREDITATION. 00084'99 7 1 (9) AN ACCREDITED LABORATORY SHALL NOT SUBCONTRACT SAMPLE 2 ANALYSES PERFORMED FOR THE PURPOSE OF DEMONSTRATING COMPLIANCE 3 WITH ANY ENVIRONMENTAL LAW, REGULATION, OR RULE IMPLEMENTED BY 4 THE DEPARTMENT, UNLESS THE SUBCONTRACTOR LABORATORY IS ACCREDITED 5 FOR THE NECESSARY CATEGORIES, PARAMETERS, ANALYTES, OR METHODS. 6 (10) AN ACCREDITED LABORATORY IS NOT ELIGIBLE TO CONTRACT 7 WITH THE DEPARTMENT FOR ON-SITE ASSESSMENT OF LABORATORIES OR TO 8 PROVIDE PT SAMPLES UNDER CONTRACT TO OR OTHERWISE APPROVED BY THE 9 DEPARTMENT. 10 (11) DEPARTMENT ON-SITE ASSESSMENT CONTRACTORS AND PROVIDERS 11 OF PT SAMPLES UNDER CONTRACT TO OR OTHERWISE APPROVED BY THE 12 DEPARTMENT ARE NOT ELIGIBLE FOR ACCREDITATION. 13 SEC. 20503. (1) UPON REQUEST FROM A LABORATORY SEEKING 14 ACCREDITATION, THE DEPARTMENT SHALL MAKE AN APPLICATION PACKAGE 15 AVAILABLE TO THE LABORATORY CONSISTING OF MATERIALS AND INFORMA- 16 TION WHICH MAY INCLUDE THE APPLICATION FORM, A COPY OF THIS PART 17 AND APPLICABLE RULES, AN ACCREDITATION MANUAL, THE ACCREDITATION 18 CATEGORIES, A LISTING OF ACCEPTABLE METHODS, LISTING OF ANALYTES 19 FOR WHICH ACCREDITATION IS AVAILABLE, THE IDENTIFICATION OF EACH 20 PT PROGRAM, AND THE NAME OF ON-SITE ASSESSMENT CONTRACTORS UNDER 21 CONTRACT TO THE DEPARTMENT. 22 (2) A LABORATORY SHALL NOT SUBMIT TO THE DEPARTMENT AND THE 23 DEPARTMENT SHALL NOT ACCEPT AN APPLICATION FOR ACCREDITATION IF 24 ACCREDITATION HAS BEEN DENIED OR THE ACCREDITATION HAS BEEN 25 REVOKED FOR THAT LABORATORY AND THE 6-MONTH PERIOD UNDER 26 SECTION 20514(4) HAS NOT EXPIRED. 00084'99 8 1 (3) THE DEPARTMENT SHALL CHARGE ACCREDITATION FEES AS 2 PROVIDED IN SECTION 20510 TO IMPLEMENT THIS PART AND OVERSEE EACH 3 CONTRACTOR HIRED OR APPROVED BY THE DEPARTMENT, AS NECESSARY, TO 4 IMPLEMENT THE ACCREDITATION PROGRAM UNDER THIS PART AND RULES 5 PROMULGATED UNDER THIS PART. A CONTRACTOR OR CONTRACTORS HIRED 6 BY THE DEPARTMENT SHALL BE THE LOWEST RESPONSIVE BIDDER OR BID- 7 DERS QUALIFIED TO UNDERTAKE THE CONTRACTUAL RESPONSIBILITIES. A 8 CONTRACTOR SHALL ASSESS FEES FOR ITS SERVICES AS ESTABLISHED IN 9 THE CONTRACT WITH THE DEPARTMENT. THE FEES SHALL BE PAID 10 DIRECTLY BY LABORATORIES THAT ARE OR SEEK TO BE ACCREDITED. 11 (4) BEFORE SUBMITTING AN APPLICATION FOR ACCREDITATION TO 12 THE DEPARTMENT, AN APPLICANT SHALL PARTICIPATE IN PT UNDER SEC- 13 TION 20508. THE PT RESULT REPORT SHALL BE SUBMITTED WITH THE 14 APPLICATION FOR ACCREDITATION. 15 (5) BEFORE SUBMITTING AN APPLICATION FOR ACCREDITATION TO 16 THE DEPARTMENT, THE APPLICANT SHALL UNDERGO AN ON-SITE ASSESSMENT 17 FROM AN ON-SITE ASSESSMENT CONTRACTOR UNDER SECTION 20509. THE 18 APPLICANT SHALL SUBMIT THE ON-SITE ASSESSMENT REPORT WITH THE 19 APPLICATION FOR ACCREDITATION. 20 (6) THE APPLICANT SHALL SUBMIT AN APPLICATION FOR ACCREDIT- 21 ATION TO THE DEPARTMENT ON FORMS PRESCRIBED BY THE DEPARTMENT. 22 THE APPLICANT SHALL SUBMIT THE ACCREDITATION FEE WITH THE 23 APPLICATION. THE APPLICATION FOR ACCREDITATION SHALL SATISFY ALL 24 OF THE FOLLOWING REQUIREMENTS: 25 (A) THE APPLICATION SHALL INCLUDE THE LEGAL NAME OF THE LAB- 26 ORATORY, LABORATORY MAILING ADDRESS, TELEPHONE NUMBER, FULL 27 ADDRESS AND LOCATION OF THE LABORATORY, THE NAME, TELEPHONE 00084'99 9 1 NUMBER, AND ADDRESS OF THE LABORATORY OWNER, NAME AND THE 2 TELEPHONE NUMBER OF THE QUALITY ASSURANCE OFFICER, NAME AND TELE- 3 PHONE NUMBER OF THE LABORATORY DIRECTOR, AND THE HOURS OF 4 OPERATION. 5 (B) THE APPLICATION SHALL INCLUDE THE SPECIFIC CATEGORIES, 6 PARAMETERS, ANALYTES, OR METHODS FOR WHICH ACCREDITATION IS 7 SOUGHT. 8 (C) THE APPLICATION SHALL INCLUDE A CERTIFICATION OF COMPLI- 9 ANCE STATEMENT SIGNED AND DATED BY THE INDIVIDUAL SPECIFIED IN 10 SUBDIVISION (D) AND WHICH STATES: 11 "_______________ ("THE APPLICANT") UNDERSTANDS AND ACKNOWLEDGES 12 THAT THE LABORATORY IS REQUIRED TO BE CONTINUALLY IN COMPLIANCE 13 WITH PART 205 (LABORATORY ACCREDITATION) OF THE NATURAL RESOURCES 14 AND ENVIRONMENTAL PROTECTION ACT, 1994 PA 451, MCL 324.20501 TO 15 324.20519, AND RULES PROMULGATED UNDER PART 205, AND IS SUBJECT 16 TO THE PENALTY PROVISIONS IN PART 205. AUTHORIZED REPRESENTA- 17 TIVES OF THE DEPARTMENT MAY MAKE ANNOUNCED OR UNANNOUNCED INSPEC- 18 TIONS OF AN APPLICANT OR ACCREDITED LABORATORY, AND REVIEW ANY 19 DATA REQUIRED TO BE SUBMITTED TO THE DEPARTMENT UNDER PART 205 20 AND RULES PROMULGATED UNDER PART 205 OR ANY INFORMATION ASSOCI- 21 ATED WITH SUCH DATA, TO DETERMINE THE EXTENT OF COMPLIANCE WITH 22 THE CONDITIONS OF ACCREDITATION AND THESE REGULATIONS. 23 ADDITIONALLY, THE APPLICANT AUTHORIZES THE OFFICIALLY DESIGNATED 24 STATE INSPECTOR TO MAKE COPIES OF ANY ANALYSES OR OTHER RECORDS 25 RELEVANT TO THE ACCREDITATION AND COMPLIANCE PROCESS, AND TO 26 REMOVE COPIES FROM THE FACILITY FOR PURPOSES OF EVALUATION OR 27 REGULATORY ENFORCEMENT. THE REFUSAL TO ALLOW ENTRY BY THE 00084'99 10 1 REPRESENTATIVES OF THE DEPARTMENT AT REASONABLE TIMES OR DURING 2 NORMAL BUSINESS HOURS OR TO ALLOW COPIES OF RECORDS RELEVANT TO 3 LABORATORY ACCREDITATION TO BE MADE IS A VIOLATION OF A CONDITION 4 OF ACCREDITATION AND SHALL RESULT IN DENIAL OR LOSS OF 5 ACCREDITATION. THE APPLICANT HEREBY CERTIFIES THAT ALL ANALYSES 6 PERFORMED ARE DONE IN ACCORDANCE WITH PART 205 AND RULES PROMUL- 7 GATED UNDER PART 205. THE UNDERSIGNED CERTIFIES THAT HE OR SHE 8 IS AUTHORIZED TO SIGN THIS APPLICATION ON BEHALF OF THE 9 APPLICANT/OWNER AND THAT BASED ON HIS OR HER KNOWLEDGE AND 10 BELIEF, THE INFORMATION PROVIDED IN THIS ACCREDITATION APPLICA- 11 TION IS ACCURATE.". 12 (D) THE APPLICATION AND THE CERTIFICATION OF COMPLIANCE 13 STATEMENT SHALL BE SIGNED AND DATED BY 1 OF THE FOLLOWING 14 INDIVIDUALS: 15 (i) IF THE APPLICANT IS A CORPORATION, A PRINCIPAL EXECUTIVE 16 OFFICER OF AT LEAST THE LEVEL OF VICE PRESIDENT. 17 (ii) IF THE APPLICANT IS A PARTNERSHIP, A GENERAL PARTNER. 18 (iii) IF THE APPLICANT IS A SOLE PROPRIETORSHIP, THE 19 PROPRIETOR. 20 (7) WITHIN 30 DAYS AFTER RECEIVING AN APPLICATION, THE 21 DEPARTMENT SHALL REVIEW THE APPLICATION, DETERMINE WHETHER THE 22 APPLICATION IS ADMINISTRATIVELY COMPLETE, AND NOTIFY THE APPLI- 23 CANT OF ANY ADDITIONAL ITEMS THAT ARE NECESSARY TO MAKE THE 24 APPLICATION ADMINISTRATIVELY COMPLETE. 25 (8) WITHIN 30 DAYS AFTER DETERMINING THAT AN APPLICATION IS 26 ADMINISTRATIVELY COMPLETE, THE DEPARTMENT SHALL REVIEW THE 27 APPLICATION, THE ON-SITE ASSESSMENT REPORT, AND THE RESULTS OF 00084'99 11 1 THE APPLICANT'S PT SAMPLES. BASED ON REVIEW OF THIS INFORMATION, 2 THE DEPARTMENT MAY APPROVE FULL ACCREDITATION FOR ALL REQUESTED 3 PARAMETERS, MAY APPROVE ACCREDITATION FOR A SUBSET OF THE 4 REQUESTED PARAMETERS AND DENY ACCREDITATION FOR OTHERS, OR MAY 5 DENY ACCREDITATION FOR ALL REQUESTED PARAMETERS. DENIAL OF 6 ACCREDITATION IS SUBJECT TO SECTION 20513. 7 (9) ACCREDITATION SHALL REMAIN IN EFFECT FOR 1 YEAR, UNLESS 8 REVOKED BY THE DEPARTMENT OR UNLESS DISCONTINUED BY ACTION OF THE 9 ACCREDITED LABORATORY. 10 (10) THE DIRECTOR OF THE DEPARTMENT OF ENVIRONMENTAL QUALITY 11 OR HIS OR HER DESIGNEE SHALL ISSUE A CERTIFICATE OF ACCREDITATION 12 TO LABORATORIES THAT COMPLY WITH THE ACCREDITATION REQUIREMENTS 13 UNDER THIS PART. THE CERTIFICATE SHALL INCLUDE THE NAME OF THE 14 LABORATORY AND THE ACCREDITATION EXPIRATION DATE AND SHALL 15 INCLUDE OR SHALL HAVE APPENDED A LIST OF THE CATEGORIES, PARAME- 16 TERS, ANALYTES, OR METHODS FOR WHICH THE LABORATORY IS 17 ACCREDITED. THE CERTIFICATE IS THE PROPERTY OF THE DEPARTMENT 18 AND SHALL BE RETURNED TO THE DEPARTMENT UPON EXPIRATION OR LOSS 19 OF ACCREDITATION. 20 (11) THE MOST CURRENT CERTIFICATE AND THE MOST CURRENT LIST 21 OF CATEGORIES, PARAMETERS, ANALYTES, OR METHODS FOR WHICH THE 22 LABORATORY IS ACCREDITED SHALL BE POSTED CONSPICUOUSLY IN THE 23 LABORATORY AND A COPY SHALL BE MADE AVAILABLE BY THE ACCREDITED 24 LABORATORY, UPON REQUEST, TO ANY PARTY UTILIZING OR REQUESTING 25 THE SERVICES OF THE LABORATORY. 26 SEC. 20504. (1) ACCREDITATION WITHIN CATEGORIES, 27 PARAMETERS, ANALYTES, OR METHODS SHALL BE RENEWED ANNUALLY. TO 00084'99 12 1 BE ELIGIBLE FOR RENEWAL OF ACCREDITATION, THE ACCREDITED 2 LABORATORY SHALL REMAIN IN COMPLIANCE WITH THE REQUIREMENTS OF 3 THIS PART AND RULES PROMULGATED UNDER THIS PART. 4 (2) THE ACCREDITED LABORATORY MAY INITIATE RENEWAL OF 5 ACCREDITATION BY SUBMITTING ALL OF THE FOLLOWING TO THE DEPART- 6 MENT WITHIN 60 DAYS BEFORE THE ANNUAL EXPIRATION DATE ESTABLISHED 7 THROUGH INITIAL ACCREDITATION: 8 (A) THE RENEWAL APPLICATION AND ALL RELEVANT INFORMATION 9 UPDATED AND SIGNED BY THE INDIVIDUAL IDENTIFIED IN 10 SECTION 20503(6)(D). APPLICATIONS FOR RENEWAL OF ACCREDITATION 11 SHALL ALSO INCLUDE THE ACCREDITATION EXPIRATION DATE AND ANY 12 DEPARTMENT-ASSIGNED LABORATORY ACCREDITATION NUMBER. 13 (B) FEES REQUIRED UNDER SECTION 20510. 14 (C) THE RESULT REPORTS OF ALL PT SAMPLES FOR ACCREDITED 15 ANALYTES OR PARAMETERS ANALYZED WITHIN THE LAST YEAR UNDER SEC- 16 TION 20508. 17 (D) A COPY OF THE MOST RECENT ON-SITE ASSESSMENT REPORT 18 UNDER SECTION 20509(3). 19 SEC. 20505. (1) AN ACCREDITED LABORATORY MAY AUGMENT THE 20 CATEGORIES, PARAMETERS, ANALYTES, OR METHODS FOR WHICH IT SEEKS 21 ACCREDITATION DURING ANNUAL RENEWAL OF ACCREDITATION UNDER SEC- 22 TION 20504. 23 (2) AT TIMES OTHER THAN DURING AN ANNUAL RENEWAL OF ACCRED- 24 ITATION, AN ACCREDITED LABORATORY MAY AUGMENT THE CATEGORIES, 25 PARAMETERS, ANALYTES, OR METHODS FOR WHICH IT IS ACCREDITED BY 26 MAKING A SEPARATE APPLICATION TO THE DEPARTMENT. 00084'99 13 1 (3) AN APPLICATION TO AUGMENT ACCREDITATION SHALL INCLUDE 2 ALL RELEVANT APPLICATION INFORMATION REQUIRED IN SECTION 20503. 3 THE LABORATORY SHALL SUBMIT THE APPLICATION FEES REQUIRED UNDER 4 SECTION 20510. 5 (4) IF A LABORATORY APPLIES TO AUGMENT ACCREDITATION FOR 2 6 OR FEWER ANALYTICAL METHODS DURING ANY 1 ACCREDITATION YEAR, THE 7 ON-SITE ASSESSMENT MAY BE DEFERRED UNTIL THE NEXT ON-SITE ASSESS- 8 MENT REQUIRED AS A PART OF THE ACCREDITATION RENEWAL PROCESS. 9 THE EVALUATION AND APPROVAL OF SUCH METHODS SHALL BE BASED ON 10 REVIEW OF THE WRITTEN STANDARD OPERATING PROCEDURE AND THE INI- 11 TIAL DEMONSTRATION OF METHOD PERFORMANCE AS SPECIFIED BY RULE. 12 (5) AN APPLICATION TO AUGMENT ACCREDITATION SHALL INCLUDE A 13 PT RESULT REPORT DEMONSTRATING SUCCESSFUL PARTICIPATION IN PT NOT 14 MORE THAN 6 MONTHS BEFORE APPLYING FOR ACCREDITATION. 15 (6) THE RENEWAL DATE FOR CATEGORIES, PARAMETERS, ANALYTES, 16 OR METHODS FOR WHICH ACCREDITATION IS AUGMENTED SHALL BE THE 17 ANNUAL ACCREDITATION RENEWAL DATE. 18 (7) AN ACCREDITED LABORATORY MAY SURRENDER ACCREDITATION FOR 19 ANY ACCREDITED CATEGORIES, PARAMETERS, ANALYTES, OR METHODS AT 20 ANY TIME BY FILING WITH THE DEPARTMENT A WRITTEN REQUEST SIGNED 21 BY THE LABORATORY DIRECTOR. 22 SEC. 20506. (1) THE DEPARTMENT MAY ENTER INTO AGREEMENTS 23 WITH THE GOVERNMENT OF ANY OTHER STATE OR THIRD PARTY NONGOVERN- 24 MENTAL ENTITY FOR THE PURPOSE OF RECOGNIZING OUT-OF-STATE ACCRED- 25 ITATION OF LABORATORIES IF SUCH AGREEMENTS ARE AUTHORIZED BY 26 RULES PROMULGATED BY THE DEPARTMENT AND IF THE DEPARTMENT 27 DETERMINES THAT ACCREDITATION STANDARDS OF THE OTHER STATE OR 00084'99 14 1 THIRD PARTY PROGRAMS ARE EQUIVALENT TO THE ACCREDITATION 2 STANDARDS OF THIS PART AND THE RULES PROMULGATED UNDER THIS 3 PART. 4 (2) THE FEES REQUIRED FOR INITIAL ACCREDITATION OR RENEWAL 5 OR AUGMENTATION OF ACCREDITATION THROUGH A RECIPROCITY AGREEMENT 6 UNDER THIS SECTION ARE THE FEES PROVIDED FOR BY SECTION 20510. 7 (3) ACCREDITATION CAN BE TRANSFERRED WHEN THE LEGAL STATUS 8 OR OWNERSHIP OF AN ACCREDITED LABORATORY CHANGES WITHOUT AFFECT- 9 ING ITS STAFF, EQUIPMENT, OR ORGANIZATION IN A MANNER THAT WOULD 10 PREVENT THE LABORATORY FROM MAINTAINING COMPLIANCE WITH THIS 11 PART. ACCREDITATION SHALL BE TRANSFERRED IF ALL OF THE FOLLOWING 12 OCCUR: 13 (A) THE CHANGE IN OWNERSHIP OF AN ACCREDITED LABORATORY IS 14 REPORTED TO THE DEPARTMENT BY THE LABORATORY DIRECTOR IN WRITING 15 WITHIN 10 BUSINESS DAYS AFTER THE CHANGE TAKES PLACE. 16 (B) THE NEW OWNER AGREES TO MAINTAIN IN ACCORDANCE WITH THIS 17 PART OR RULES PROMULGATED UNDER THIS PART RECORDS, DATA, AND 18 REPORTS FOR ANY ANALYSES GENERATED BEFORE LEGAL TRANSFER OF 19 OWNERSHIP. 20 (C) THE NEW OWNER PAYS A TRANSFER FEE TO THE DEPARTMENT. 21 SEC. 20507. (1) THE DEPARTMENT SHALL DO ALL OF THE 22 FOLLOWING: 23 (A) DEVELOP AN ACCREDITATION MANUAL DETAILING THE REGULA- 24 TIONS, REQUIREMENTS, GUIDANCE, AND ACCREDITATION PROCEDURES FOR 25 ACCREDITATION UNDER THIS PART. 26 (B) DEFINE THE CATEGORIES, PARAMETERS, ANALYTES, AND 27 ACCEPTABLE METHODS FOR WHICH A LABORATORY MAY BECOME ACCREDITED. 00084'99 15 1 (C) COMPILE AND MAINTAIN A LISTING OF COMMERCIAL ACCREDITED 2 LABORATORIES THAT INCLUDES THE NAME OF EACH LABORATORY, THE NAME 3 OF THE LABORATORY DIRECTOR, THE MAILING ADDRESS AND TELEPHONE 4 NUMBER OF THE LABORATORY, AND THE CATEGORIES FOR WHICH THE LABO- 5 RATORY IS ACCREDITED. THIS LISTING SHALL BE REVISED AT LEAST 6 ANNUALLY AND SHALL BE AVAILABLE ON REQUEST WITHOUT CHARGE. 7 (2) THE DEPARTMENT MAY DO 1 OR MORE OF THE FOLLOWING: 8 (A) APPROVE THE USE OF ALTERNATIVE TEST PROCEDURES THAT ARE 9 APPROVED BY THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY FOR 10 A SIMILAR USE. 11 (B) APPROVE THE USE OF ALTERNATIVE TEST PROCEDURES IF THE 12 APPLICANT DOCUMENTS THAT THE QUALITY OF DATA PRODUCED BY THE PRO- 13 POSED METHOD IS AS GOOD OR BETTER THAN THE QUALITY OF DATA 14 PRODUCED BY THE EXISTING APPROVED METHOD. 15 (C) APPROVE AN ANALYTICAL METHOD IS THERE IS NO DEPARTMENT 16 APPROVED METHOD OR IF NO METHOD EXISTS. 17 (D) UNDERTAKE DOUBLE BLIND PT STUDIES OF ACCREDITED LABORA- 18 TORIES THROUGH THE USE OF SAMPLES FROM A PT PROGRAM OR SAMPLES 19 FROM OTHER QUALIFIED SOURCES. THE DEPARTMENT MAY USE THE RESULTS 20 OF SUCH PT SAMPLES TO SELECT LABORATORIES FOR FURTHER INSPECTION, 21 REQUIRE ANALYSIS OF PT SAMPLES IN THE PRESENCE OF DEPARTMENT REP- 22 RESENTATIVES, REQUIRE CORRECTIVE ACTION, REVOKE ACCREDITATION 23 SUBJECT TO THE ADMINISTRATIVE PROCEDURES ACT OF 1969, 1969 PA 24 306, MCL 24.201 TO 24.328, OR REQUEST THE ATTORNEY GENERAL TO 25 COMMENCE A CIVIL ACTION AS DESCRIBED IN SECTION 20516. 26 (E) ENTER INTO AGREEMENTS, CONTRACTS, OR COOPERATIVE 27 ARRANGEMENTS UNDER TERMS AND CONDITIONS APPROPRIATE WITH OTHER 00084'99 16 1 STATE AGENCIES, FEDERAL AGENCIES, INTERSTATE AGENCIES, POLITICAL 2 SUBDIVISIONS, EDUCATIONAL INSTITUTIONS, LOCAL HEALTH DEPARTMENTS, 3 OR OTHER PUBLIC OR PRIVATE ORGANIZATIONS, OR INDIVIDUALS TO 4 ADMINISTER THIS PART. 5 SEC. 20508. (1) ALL OF THE FOLLOWING PT REQUIREMENTS SHALL 6 BE MET: 7 (A) THE LABORATORY SHALL PARTICIPATE IN PT FOR ALL CATEGO- 8 RIES, PARAMETERS, ANALYTES, AND METHODS FOR WHICH THE LABORATORY 9 IS ACCREDITED AND FOR WHICH A PT PROGRAM EXISTS. 10 (B) THE LABORATORY SHALL PAY ALL COSTS OF PT REQUIRED FOR 11 ACCREDITATION. 12 (C) THE PT RESULT REPORT SHALL BE PROVIDED WITH THE INITIAL 13 APPLICATION FOR ACCREDITATION AND ANY APPLICATION TO AUGMENT 14 ACCREDITATION. AFTER ACCREDITATION IS GRANTED, EACH LABORATORY 15 SHALL PROVIDE THE PT RESULT REPORT TO THE DEPARTMENT, WITHIN 30 16 DAYS FOLLOWING RECEIPT OF THE REPORT. 17 (D) A LABORATORY SHALL EXAMINE OR TEST, AS APPLICABLE, THE 18 PT SAMPLES RECEIVED FROM THE PT PROGRAM IN THE SAME MANNER AS 19 ROUTINE ENVIRONMENTAL SAMPLES. EACH ANALYST RESPONSIBLE FOR 20 ANALYSIS OF A PT SAMPLE SHALL TEST THE PT SAMPLE THE SAME NUMBER 21 OF TIMES THAT ROUTINE TESTS ON ENVIRONMENTAL SAMPLES ARE 22 PERFORMED. THE LABORATORY DIRECTOR AND EACH ANALYST SHALL ALSO 23 SIGN THE PT RESULT REPORT OR A STATEMENT ATTACHED TO THE PT 24 RESULT REPORT ATTESTING THAT ALL SAMPLES WERE ANALYZED IN THE 25 SAME MANNER AS ROUTINE SAMPLES. ALL ANALYST SIGNATURES SHALL BE 26 LINKED TO THE PT SAMPLE ANALYZED SO THAT THE ANALYST RESPONSIBLE 27 FOR EACH PT SAMPLE IS CLEARLY IDENTIFIED. THESE SIGNED 00084'99 17 1 STATEMENTS SHALL ACCOMPANY THE LABORATORY RESULTS TO THE PT 2 PROGRAM. 3 (E) PT SAMPLE RESULTS FROM THE PARTICIPATING LABORATORY 4 SHALL BE REPORTED TO THE PT PROGRAM WITHIN THE DEADLINE STATED IN 5 THE SAMPLE PACKAGE. 6 (2) FOR AN ACCREDITATION PARAMETER OR ANALYTE FOR WHICH A PT 7 SAMPLE OR SAMPLES ARE NOT CURRENTLY AVAILABLE, AS DETERMINED BY 8 THE DEPARTMENT, THE LABORATORY SHALL ESTABLISH AND MAINTAIN THE 9 ACCURACY AND RELIABILITY OF TESTING PROCEDURES BY A SYSTEM OF 10 INTERNAL MANAGEMENT AS DESCRIBED IN RULES PROMULGATED UNDER THIS 11 PART. 12 (3) ANY APPLICANT OR ACCREDITED LABORATORY PARTICIPATING IN 13 PT SHALL COMPLY WITH ALL OF THE FOLLOWING REQUIREMENTS: 14 (A) A LABORATORY SHALL NOT ENGAGE IN COMMUNICATIONS WITH 15 ANOTHER LABORATORY PERTAINING TO THE PT SAMPLE RESULTS BEFORE THE 16 DEADLINE FOR REPORTING PT SAMPLE RESULTS. 17 (B) LABORATORIES SHALL NOT SEND A PT SAMPLE OR A PORTION OF 18 A PT SAMPLE TO ANOTHER LABORATORY FOR ANY ANALYSIS FOR WHICH 19 ACCREDITATION IS SOUGHT. ANY LABORATORY THAT THE DEPARTMENT 20 DETERMINES REFERRED A PT SAMPLE TO ANOTHER LABORATORY FOR ANALY- 21 SIS SHALL BE DENIED ACCREDITATION OR HAVE ITS ACCREDITATION PER- 22 MANENTLY REVOKED FOR ALL CATEGORIES, PARAMETERS, ANALYTES, OR 23 METHODS. ANY LABORATORY THAT RECEIVES A PT SAMPLE FROM ANOTHER 24 LABORATORY FOR TESTING SHALL IMMEDIATELY NOTIFY THE DEPARTMENT OF 25 THE RECEIPT OF THE PT SAMPLE AND SHALL PROVIDE TO THE DEPARTMENT 26 ALL INFORMATION ASSOCIATED WITH THE RECEIPT OF THE PT SAMPLE. 27 THE DEPARTMENT SHALL DENY OR REVOKE FOR 6 MONTHS ACCREDITATION OF 00084'99 18 1 AN APPLICANT OR ACCREDITED LABORATORY THAT DOES NOT REPORT THE 2 RECEIPT OF A PT SAMPLE FROM ANOTHER LABORATORY. 3 (C) A LABORATORY SHALL INITIATE CHAIN OF CUSTODY PROCEDURES 4 UPON RECEIPT OF A PT SAMPLE. THE LABORATORY SHALL MAINTAIN A 5 COPY OF ALL RECORDS ASSOCIATED WITH THE ANALYSIS OF A PT SAMPLE, 6 INCLUDING ANALYTICAL WORKSHEETS, FOR A MINIMUM OF 5 YEARS. THIS 7 RECORD SHALL INCLUDE A COPY OF COMPLETED PT RESULT REPORT FORMS 8 USED BY THE LABORATORY TO RECORD PT RESULTS, INCLUDING THE STATE- 9 MENTS SIGNED BY THE APPROPRIATE ANALYSTS AND THE LABORATORY 10 DIRECTOR STATING THAT PT SAMPLES WERE TESTED IN THE SAME MANNER 11 AS ROUTINE ENVIRONMENTAL SAMPLES AS DESCRIBED IN SUBSECTION 12 (1)(D). 13 (4) AN APPLICANT SHALL PARTICIPATE IN PT NOT MORE THAN 6 14 MONTHS BEFORE MAKING APPLICATION TO THE DEPARTMENT. A PT SAMPLE 15 MAY CONSIST OF EITHER 1 OR 2 CONCENTRATIONS AS DETERMINED BY THE 16 DEPARTMENT. IF THE PT SAMPLE CONSISTS OF 1 CONCENTRATION, THE 17 SINGLE RESULT SHALL BE WITHIN THE ACCEPTANCE LIMIT TO BE ELIGIBLE 18 FOR ACCREDITATION. IF THE PT SAMPLE CONSISTS OF 2 CONCENTRA- 19 TIONS, BOTH RESULTS SHALL BE WITHIN ACCEPTANCE LIMITS TO BE ELI- 20 GIBLE FOR ACCREDITATION. 21 (5) AN ACCREDITED LABORATORY SEEKING TO MAINTAIN OR RENEW 22 ACCREDITATION SHALL PARTICIPATE IN PT TWICE. THE FIRST PT SHALL 23 BE COMPLETED NOT LESS THAN 6 AND NOT MORE THAN 12 MONTHS BEFORE 24 THE ACCREDITATION EXPIRATION DATE AND THE SECOND PT SHALL BE COM- 25 PLETED NOT MORE THAN 6 MONTHS BEFORE THE ACCREDITATION EXPIRATION 26 DATE. A PT SAMPLE MAY CONSIST OF EITHER 1 OR 2 CONCENTRATIONS AS 27 DETERMINED BY THE DEPARTMENT. 00084'99 19 1 (6) IF THE PT SAMPLE ANALYZED SEMIANNUALLY BY AN ACCREDITED 2 LABORATORY CONSISTS OF 1 CONCENTRATION, THEN BOTH SEMIANNUAL PT 3 SAMPLE RESULTS SHALL BE WITHIN ACCEPTANCE LIMITS. IF EITHER OR 4 BOTH PT RESULTS ARE NOT WITHIN ACCEPTANCE LIMITS, THE LABORATORY 5 SHALL BE PROVISIONALLY ACCREDITED AND SHALL REANALYZE A REMEDIAL 6 PT SAMPLE NOT MORE THAN 30 DAYS AFTER RECEIVING THE UNACCEPTABLE 7 PT RESULT. IF THE REMEDIAL PT SAMPLE RESULT IS ACCEPTABLE, 8 ACCREDITATION FOR THAT ANALYTE IS RESTORED. IF THE REMEDIAL PT 9 RESULT IS NOT WITHIN ACCEPTANCE LIMITS, ACCREDITATION FOR THAT 10 ANALYTE IS REVOKED. TO BECOME REACCREDITED, THE LABORATORY SHALL 11 REAPPLY FOR ACCREDITATION FOR THE AFFECTED ANALYTES THROUGH 12 EITHER AN APPLICATION TO RENEW OR AUGMENT ACCREDITATION. 13 (7) IF THE PT SAMPLE ANALYZED SEMIANNUALLY BY AN ACCREDITED 14 LABORATORY CONSISTS OF 2 CONCENTRATIONS, THEN 3 OF THE 4 SEMIAN- 15 NUAL PT RESULTS SHALL BE WITHIN ACCEPTANCE LIMITS. IF LESS THAN 16 3 OF THE 4 PT RESULTS ARE WITHIN ACCEPTANCE LIMITS, THEN ACCRED- 17 ITATION IS DOWNGRADED TO PROVISIONAL AND THE LABORATORY SHALL 18 REANALYZE A REMEDIAL PT SAMPLE NOT MORE THAN 30 DAYS AFTER 19 RECEIVING THE UNACCEPTABLE PT SAMPLE RESULT. IF THE PT RESULTS 20 FOR BOTH CONCENTRATIONS OF THE REMEDIAL PT SAMPLE ARE WITHIN 21 ACCEPTANCE LIMITS, THEN FULL ACCREDITATION IS RESTORED. IF THE 22 PT RESULTS FOR 1 OR BOTH CONCENTRATIONS OF THE REMEDIAL PT SAMPLE 23 ARE OUTSIDE ACCEPTANCE LIMITS, THEN ACCREDITATION FOR THAT ANAL- 24 YTE IS REVOKED. TO BECOME REACCREDITED, THE LABORATORY SHALL 25 REAPPLY FOR ACCREDITATION FOR THE AFFECTED ANALYTES THROUGH AN 26 APPLICATION TO RENEW OR AUGMENT ACCREDITATION. 00084'99 20 1 (8) THE CORRECTIVE ACTIONS TAKEN TO RESOLVE UNACCEPTABLE PT 2 RESULTS SHALL BE THOROUGHLY DOCUMENTED, AND THE DOCUMENTATION 3 SHALL BE MAINTAINED BY THE LABORATORY FOR AT LEAST 5 YEARS FROM 4 THE DATE OF PARTICIPATION IN THE PT. 5 (9) FAILURE TO RETURN PT RESULTS TO THE PT PROGRAM WITHIN 6 THE TIME DEADLINE SPECIFIED BY THE PT PROGRAM IS AN UNACCEPTABLE 7 RESULT. HOWEVER, THE DEPARTMENT MAY EXTEND A DEADLINE IF IT 8 DETERMINES THAT THE CAUSE OF THE FAILURE WAS BEYOND THE CONTROL 9 OF THE LABORATORY. 10 (10) A LABORATORY SHALL TEST ADDITIONAL PT SAMPLES AT THE 11 REQUEST OF THE DEPARTMENT IF THE DEPARTMENT DETERMINES THAT 1 OR 12 MORE OF THE FOLLOWING APPLY: 13 (A) THERE HAS BEEN A MAJOR CHANGE IN OWNERSHIP OR SUPERVI- 14 SION OF THE LABORATORY. 15 (B) A LABORATORY CLIENT OR EMPLOYEE HAS ALLEGED SIGNIFICANT 16 NONCOMPLIANCE WITH THIS PART BY THE LABORATORY. 17 (C) THE LABORATORY OBTAINED UNACCEPTABLE RESULTS ON THE MOST 18 RECENT PT. 19 (D) THE LABORATORY MUST DEMONSTRATE CORRECTIVE ACTION FOL- 20 LOWING AN UNACCEPTABLE ON-SITE ASSESSMENT. 21 SEC. 20509. (1) APPLICANT LABORATORIES AND ACCREDITED LABO- 22 RATORIES SHALL BE EVALUATED FOR COMPLIANCE WITH THE ACCREDITATION 23 REQUIREMENTS OF THIS PART BY AN ON-SITE ASSESSMENT CONTRACTOR. 24 (2) TO OBTAIN INITIAL ACCREDITATION OR TO AUGMENT ACCREDIT- 25 ATION, THE APPLICANT LABORATORY SHALL, NOT MORE THAN 1 YEAR 26 BEFORE APPLYING FOR ACCREDITATION, PASS AN ON-SITE ASSESSMENT 27 CONSISTENT WITH THE ON-SITE ASSESSMENT STANDARDS IN THIS PART AND 00084'99 21 1 RULES PROMULGATED UNDER THIS PART. THE APPLICANT SHALL SCHEDULE 2 AN ON-SITE ASSESSMENT WITH THE ON-SITE ASSESSMENT CONTRACTOR. 3 THE ON-SITE ASSESSMENT CONTRACTOR SHALL PERFORM AN ON-SITE 4 ASSESSMENT OF THE LABORATORY, PREPARE AN ON-SITE ASSESSMENT 5 REPORT, AND SUBMIT THE REPORT TO THE APPLICANT. IF THE ON-SITE 6 ASSESSMENT INDICATES SIGNIFICANT DEFICIENCIES, THE APPLICANT MAY 7 CORRECT THE DEFICIENCIES AND REPEAT THE ON-SITE ASSESSMENT OR 8 PORTION OF THE ON-SITE ASSESSMENT, AS APPROPRIATE. THE APPLICANT 9 SHALL SUBMIT THE ON-SITE ASSESSMENT REPORT TO THE DEPARTMENT AS A 10 PART OF THE APPLICATION FOR INITIAL ACCREDITATION OR THE APPLICA- 11 TION TO AUGMENT ACCREDITATION, AS APPROPRIATE. THE DEPARTMENT 12 SHALL NOT APPROVE AN APPLICATION FOR ACCREDITATION, UNLESS THE 13 DEPARTMENT HAS FOUND THAT THE ON-SITE ASSESSMENT REPORT IS 14 ACCEPTABLE. THE DEPARTMENT SHALL REVIEW THE APPLICATION, INCLUD- 15 ING THE ON-SITE ASSESSMENT REPORT, SUBJECT TO SECTION 20503(7) 16 AND (8). APPLICATION DENIAL IS SUBJECT TO SECTION 20513. 17 (3) TO RENEW ACCREDITATION, THE ACCREDITED LABORATORY SHALL 18 PASS AN ON-SITE ASSESSMENT NOT MORE THAN 2 YEARS BEFORE EXPIRA- 19 TION OF THE CURRENT ACCREDITATION PERIOD. IF AN ON-SITE ASSESS- 20 MENT IS REQUIRED, THE LABORATORY SHALL FORWARD A COPY OF THE 21 ON-SITE ASSESSMENT REPORT TO THE DEPARTMENT NOT MORE THAN 10 DAYS 22 AFTER RECEIVING THE ON-SITE ASSESSMENT REPORT FROM THE ON-SITE 23 ASSESSMENT CONTRACTOR. 24 (4) THE ON-SITE ASSESSMENT CONTRACTOR SHALL PROVIDE COPIES 25 OF THE ON-SITE ASSESSMENT TO BOTH THE LABORATORY AND THE DEPART- 26 MENT NOT MORE THAN 30 BUSINESS DAYS AFTER COMPLETING THE ON-SITE 27 ASSESSMENT. THE DEPARTMENT SHALL REVIEW THE ON-SITE ASSESSMENT 00084'99 22 1 REPORT AND NOTIFY THE LABORATORY OF ANY EXISTING DEFICIENCIES NOT 2 MORE THAN 30 BUSINESS DAYS AFTER RECEIVING THE ON-SITE ASSESSMENT 3 REPORT. NOT MORE THAN 20 BUSINESS DAYS AFTER NOTIFICATION THAT A 4 DEFICIENCY EXISTS, THE LABORATORY SHALL EITHER CORRECT THE DEFI- 5 CIENCY AND PROVIDE DOCUMENTATION TO THE DEPARTMENT THAT THE DEFI- 6 CIENCY HAS BEEN CORRECTED OR SUBMIT A CORRECTIVE ACTION PLAN TO 7 THE DEPARTMENT UNDER SUBSECTION (5). IF THE LABORATORY CHOOSES 8 TO CORRECT THE DEFICIENCY AND SUBMIT DOCUMENTATION TO THE DEPART- 9 MENT DEMONSTRATING THAT THE DEFICIENCY HAS BEEN CORRECTED AND IF 10 SUBSEQUENT DEPARTMENT REVIEW OF THIS SUBMITTAL DETERMINES THE 11 DOCUMENTATION OR DEMONSTRATION IS DEFICIENT, THE DEPARTMENT MAY 12 GRANT THE LABORATORY AN ADDITIONAL 20 BUSINESS DAYS TO PERFORM 13 CORRECTIVE ACTION AND SUBMIT DOCUMENTATION OF THE CORRECTIVE 14 ACTION BEFORE THE DEPARTMENT REVOKES ACCREDITATION. 15 (5) IF THE LABORATORY SUBMITS A CORRECTIVE ACTION PLAN, THE 16 PLAN SHALL HAVE A COMPLETION DATE OF NOT MORE THAN 6 MONTHS FROM 17 DEPARTMENT ACCEPTANCE OF THE PLAN. NOT MORE THAN 30 BUSINESS 18 DAYS AFTER RECEIPT OF THE PLAN, THE DEPARTMENT SHALL REVIEW THE 19 PLAN AND NOTIFY THE LABORATORY THAT THE DEPARTMENT EITHER ACCEPTS 20 OR REJECTS THE PLAN, AS APPLICABLE. IF THE DEPARTMENT REJECTS 21 THE PLAN, THE NOTIFICATION SHALL IDENTIFY CHANGES THAT WOULD MAKE 22 THE CORRECTIVE ACTION PLAN ACCEPTABLE. IF THE DEPARTMENT DETER- 23 MINES THAT ALL DEFICIENCIES WERE NOT CORRECTED WITHIN 6 MONTHS OF 24 ACCEPTING THE CORRECTIVE ACTION PLAN OR NOTIFYING THE LABORATORY 25 OF THE CHANGES REQUIRED TO MAKE THE CORRECTIVE ACTION PLAN 26 ACCEPTABLE, THE DEPARTMENT SHALL REVOKE ACCREDITATION. 00084'99 23 1 (6) IN ADDITION TO ON-SITE ASSESSMENTS REQUIRED AS A PART OF 2 AN APPLICATION FOR INITIAL ACCREDITATION OR TO RENEW OR AUGMENT 3 ACCREDITATION, THE DEPARTMENT MAY REQUIRE FOLLOW-UP ASSESSMENTS 4 TO VERIFY THAT THE CAUSE OF AN UNSATISFACTORY ON-SITE ASSESSMENT 5 HAS BEEN CORRECTED OR TO DETERMINE THE CAUSE OF RECURRING UNAC- 6 CEPTABLE PT RESULTS. THESE ON-SITE ASSESSMENTS SHALL BE PAID FOR 7 BY THE LABORATORY. 8 (7) THE DEPARTMENT MAY REQUIRE A NEW OR PARTIAL ON-SITE 9 ASSESSMENT IF THE DEPARTMENT DETERMINES THAT A MAJOR CHANGE HAS 10 OCCURRED AT A LABORATORY IN PERSONNEL, EQUIPMENT, OR THE FACILITY 11 THAT MIGHT IMPAIR THE CAPABILITY OF THE LABORATORY TO PERFORM 12 ACCEPTABLE ANALYSIS OF PARAMETERS, METHODS, OR ANALYTES FOR WHICH 13 THE LABORATORY IS ACCREDITED. A MAJOR CHANGE IN PERSONNEL 14 INCLUDES THE LOSS OR REPLACEMENT OF A KEY MEMBER OF THE LABORA- 15 TORY MANAGEMENT STAFF OR LOSS OF THE ONLY TRAINED AND EXPERIENCED 16 INDIVIDUAL WHO PERFORMS A PARTICULAR TEST FOR WHICH ACCREDITATION 17 HAS BEEN GRANTED. 18 (8) THE DEPARTMENT IS NOT REQUIRED TO PROVIDE ADVANCE NOTICE 19 OF AN ON-SITE ASSESSMENT WHEN AN ON-SITE ASSESSMENT IS CONDUCTED 20 AT DEPARTMENT EXPENSE. 21 (9) THE LABORATORY SHALL PERFORM PT SAMPLE ANALYSIS IN THE 22 PRESENCE OF DEPARTMENT REPRESENTATIVES OR DURING AN ON-SITE 23 ASSESSMENT IF REQUESTED TO DO SO BY THE DEPARTMENT. 24 SEC. 20510. (1) A LABORATORY APPLYING FOR INITIAL ACCREDIT- 25 ATION OR TO RENEW OR AUGMENT ACCREDITATION SHALL SUBMIT ALL FEES 26 REQUIRED UNDER THIS SECTION WITH THE APPLICATION FOR 27 ACCREDITATION. FEES ARE NONREFUNDABLE EXCEPT FOR OVERPAYMENT. 00084'99 24 1 SUBJECT TO SUBSECTIONS (2) TO (8), THE ACCREDITATION FEE SHALL BE 2 THE SUM OF THE FEE FOR EACH ACCREDITATION CATEGORY PLUS EITHER 3 THE INITIAL APPLICATION FEE, THE AUGMENTATION FEE, OR THE RENEWAL 4 APPLICATION FEE AS PROVIDED IN THE FOLLOWING FEE SCHEDULE: 5 FOR INITIAL ACCREDITATION.................... $ 400.00 6 TO ANNUALLY RENEW ACCREDITATION.............. $ 200.00 7 TO AUGMENT ACCREDITATION..................... $ 150.00 8 FEE PER ACCREDITATION CATEGORY............... $ 100.00 9 (2) A FEE TO AUGMENT ACCREDITATION IS NOT REQUIRED IF THE 10 LABORATORY APPLIES TO AUGMENT ACCREDITATION AT THE SAME TIME IT 11 APPLIES TO ANNUALLY RENEW ACCREDITATION. 12 (3) ACCREDITATION MAY BE TRANSFERRED WHEN OWNERSHIP OF AN 13 ACCREDITED LABORATORY CHANGES, SUBJECT TO SECTION 20506(3). THE 14 ACCREDITATION TRANSFER FEE IS $100.00. 15 (4) THE ACCREDITATION FEE FOR EACH MOBILE LABORATORY UNIT 16 THAT IS ACCREDITED AS PART OF A STATIONARY LABORATORY UNDER SEC- 17 TION 20502(7) IS $100.00 PER MOBILE LABORATORY UNIT PLUS THE 18 APPROPRIATE CATEGORY FEE OR FEES. 19 (5) THE ACCREDITATION FEE FOR MOBILE LABORATORIES ACCREDITED 20 AS A SINGLE LABORATORY UNDER SECTION 20502(8) IS THE FEE DETER- 21 MINED UNDER SUBSECTION (1) FOR THE FIRST LABORATORY PLUS, FOR 22 EACH ADDITIONAL MOBILE LABORATORY, THE SUM OF $100.00 AND THE 23 APPROPRIATE CATEGORY FEE OR FEES. 24 (6) THE DEPARTMENT SHALL ADJUST FEES EACH YEAR BASED ON THE 25 CONSUMER PRICE INDEX. THE DEPARTMENT SHALL DETERMINE ON OR 26 BEFORE DECEMBER 15 OF EACH YEAR, BEGINNING DECEMBER 15, 1997, AN 27 ADJUSTED AMOUNT FOR THE FOLLOWING YEAR. THE ADJUSTED AMOUNT FOR 00084'99 25 1 EACH YEAR SHALL BE DETERMINED BY COMPARING THE CONSUMER PRICE 2 INDEX FOR THE 12-MONTH PERIOD ENDING THE PRECEDING OCTOBER 31 3 WITH THE CORRESPONDING CONSUMER PRICE INDEX OF 1 YEAR EARLIER. 4 THE PERCENTAGE INCREASE OR DECREASE SHALL THEN BE MULTIPLIED BY 5 THE CURRENT ADJUSTED AMOUNT. THE PRODUCT, ROUNDED UP TO THE 6 NEAREST MULTIPLE OF $1.00, SHALL BE THE NEW ADJUSTED AMOUNT. THE 7 DEPARTMENT SHALL PROVIDE THE ADJUSTED AMOUNT UPON REQUEST. 8 (7) IN ADDITION TO THE FEES ASSESSED BY THE DEPARTMENT, AN 9 APPLICANT FOR ACCREDITATION SHALL PAY THE FEES REQUIRED BY THE 10 ON-SITE ASSESSMENT CONTRACTOR AS ESTABLISHED IN THE CONTRACT 11 BETWEEN THE DEPARTMENT AND THE CONTRACTOR, AND ANY FEES ASSOCI- 12 ATED WITH PT. 13 (8) WITHIN 14 DAYS AFTER THE DEPARTMENTS ENTER INTO A CON- 14 TRACT WITH AN ON-SITE ASSESSMENT CONTRACTOR, THE DEPARTMENT SHALL 15 NOTIFY THE CHAIRPERSONS OF THE COMMITTEES OF THE SENATE AND THE 16 HOUSE OF REPRESENTATIVES THAT ARE PRIMARILY RESPONSIBLE FOR ENVI- 17 RONMENTAL PROTECTION LEGISLATION OF THE FEES TO BE CHARGED BY THE 18 ON-SITE ASSESSMENT CONTRACTOR. 19 (9) FEES UNDER THIS PART SHALL BE DEPOSITED IN THE ENVIRON- 20 MENTAL RESPONSE FUND SUBACCOUNT OF THE CLEANUP AND REDEVELOPMENT 21 FUND CREATED UNDER SECTION 20108. 22 SEC. 20511. (1) AN ACCREDITED LABORATORY SHALL ASSURE THAT 23 THE QUALITY OF ANALYTICAL DATA PRODUCED BY THE LABORATORY IS 24 SUITABLE FOR ITS INTENDED PURPOSE AND IS SUPPORTED BY APPROPRIATE 25 DOCUMENTATION. AN ACCREDITED LABORATORY SHALL ASSURE THAT THE 26 QUALITY OF ANALYTICAL DATA IS MAINTAINED WITHIN A FRAMEWORK OF 27 QUALITY SYSTEMS IN WHICH STAFF RESPONSIBILITIES AND OPERATIONAL 00084'99 26 1 PROCEDURES ARE DEFINED, DOCUMENTED, AND SUBJECTED TO AUDIT ON A 2 REGULAR BASIS, WITH TIMELY CORRECTIVE ACTION TAKEN BY THE LABORA- 3 TORY AS NEEDED. 4 (2) THE QUALITY SYSTEMS SHALL INCLUDE ALL QUALITY ASSURANCE 5 POLICIES AND QUALITY CONTROL PROCEDURES AND SHALL BE DOCUMENTED 6 IN A LABORATORY QUALITY ASSURANCE PLAN. THE LABORATORY SHALL 7 MEET ANY ADDITIONAL OR MORE STRINGENT REQUIREMENTS SPECIFIED BY 8 ANALYTICAL METHODS OR SPECIFIC REGULATORY PROGRAMS FOR WHICH THE 9 DATA IS BEING USED TO DEMONSTRATE COMPLIANCE. 10 SEC. 20512. (1) AN ACCREDITED LABORATORY SHALL PROVIDE THE 11 LABORATORY ACCREDITATION NUMBER, EXPIRATION DATE, AND VALIDATION 12 STATEMENT SIGNED BY THE LABORATORY DIRECTOR WITH EACH SET OF 13 RESULTS. THE VALIDATION STATEMENT SHALL READ, "I CERTIFY THAT I 14 AM THE LABORATORY DIRECTOR WITH ULTIMATE RESPONSIBILITY FOR LABO- 15 RATORY OPERATIONS AND THAT, TO THE BEST OF MY KNOWLEDGE, THESE 16 ANALYSES WERE PERFORMED, AND THE RESULTS ARE REPORTED, IN FULL 17 COMPLIANCE WITH PART 205 OF THE NATURAL RESOURCES AND ENVIRONMEN- 18 TAL PROTECTION ACT, 1994 PA 451, MCL 324.20501 TO 324.20519, AND 19 RULES PROMULGATED UNDER PART 205.". 20 (2) THE LABORATORY SHALL MAINTAIN ALL LABORATORY RECORDS 21 ASSOCIATED WITH ACCREDITATION PARAMETERS OR SPECIFIED IN ADMINIS- 22 TRATIVE RULES, INCLUDING RAW DATA ASSOCIATED WITH EACH ANALYSIS, 23 CHANGES IN METHOD STANDARD OPERATING PROCEDURES, AND THE LABORA- 24 TORY QUALITY ASSURANCE PLAN, FOR A MINIMUM OF 5 YEARS UNLESS A 25 LONGER PERIOD IS SPECIFIED IN A RULE PROMULGATED UNDER THIS 26 PART. 00084'99 27 1 (3) THE LABORATORY DIRECTOR OF AN ACCREDITED LABORATORY 2 SHALL NOTIFY THE DEPARTMENT OF ANY CHANGES IN KEY ACCREDITATION 3 CRITERIA INCLUDING THE LABORATORY LOCATION, OR THE LOSS OF KEY 4 PERSONNEL, WITHIN 30 DAYS FOLLOWING THE CHANGES. 5 SEC. 20513. (1) THE DEPARTMENT SHALL DENY AN APPLICATION 6 FOR INITIAL ACCREDITATION OR TO RENEW OR AUGMENT ACCREDITATION IF 7 ANY OF THE FOLLOWING OCCUR: 8 (A) FAILURE TO PARTICIPATE OR UNSATISFACTORY PERFORMANCE IN 9 PT AS REQUIRED BY THE DEPARTMENT. 10 (B) FAILURE TO SUBMIT THE CERTIFICATION OF COMPLIANCE STATE- 11 MENT WITH THE APPLICATION AS REQUIRED BY SECTION 20503. 12 (C) SUBMISSION OF PT RESULTS GENERATED BY ANOTHER 13 LABORATORY. 14 (D) FALSIFICATION OF ANY REPORT OF OR RELATING TO A LABORA- 15 TORY ANALYSIS. 16 (E) FAILURE TO PAY THE APPROPRIATE ACCREDITATION FEE WITH 17 THE APPLICATION. 18 (F) AN UNACCEPTABLE ON-SITE ASSESSMENT, SUBJECT TO SECTION 19 20509. 20 (G) MISREPRESENTATION OF ANY MATERIAL FACT PERTINENT TO THE 21 APPLICATION PROCESS. 22 (2) DENIAL OF ACCREDITATION SHALL OCCUR FOR SPECIFIC CATEGO- 23 RIES, PARAMETERS, ANALYTES, OR METHODS FOR THOSE INSTANCES WHERE 24 UNSATISFACTORY LABORATORY PERFORMANCE, PRACTICES, OR ACTIONS ARE 25 SPECIFIC TO SUCH CATEGORIES, PARAMETERS, ANALYTES, OR METHODS. 26 (3) THE DEPARTMENT SHALL NOTIFY THE APPLICANT OF THE 27 DEPARTMENT'S INTENT TO DENY ACCREDITATION AND IDENTIFY THE BASIS 00084'99 28 1 FOR DENIAL. IF THE BASIS FOR DENIAL IS AN UNACCEPTABLE ON-SITE 2 ASSESSMENT, AFTER RECEIVING NOTICE THAT THE DEPARTMENT INTENDS TO 3 DENY THE ACCREDITATION, THE APPLICANT SHALL HAVE 1 OPPORTUNITY TO 4 CORRECT THE DEFICIENCIES CAUSING THE ON-SITE ASSESSMENT TO BE 5 UNACCEPTABLE. IF THE APPLICANT OPTS TO CORRECT THESE DEFICIEN- 6 CIES, THE APPLICANT SHALL SO NOTIFY THE DEPARTMENT NOT MORE THAN 7 10 DAYS AFTER RECEIVING THE DEPARTMENT NOTICE OF INTENT TO DENY 8 ACCREDITATION. AT THE REQUEST OF AN APPLICANT FOR INITIAL 9 ACCREDITATION OR TO AUGMENT ACCREDITATION, THE DEPARTMENT SHALL 10 HOLD THE APPLICATION IN ABEYANCE FOR NOT MORE THAN 6 MONTHS FROM 11 THE DATE THE DEPARTMENT NOTIFIED THE APPLICANT OF THE 12 DEPARTMENT'S INTENT TO DENY ACCREDITATION TO ALLOW THE APPLICANT 13 TO DEMONSTRATE THAT DEFICIENCIES HAVE BEEN CORRECTED. AT THE 14 REQUEST OF AN APPLICANT TO RENEW ACCREDITATION, THE DEPARTMENT 15 SHALL HOLD THE APPLICATION IN ABEYANCE FOR NOT MORE THAN 1 MONTH 16 AFTER THE EXPIRATION OF THE CURRENT ACCREDITATION TO ALLOW THE 17 APPLICANT TO DEMONSTRATE THAT DEFICIENCIES HAVE BEEN CORRECTED. 18 IF THE DEPARTMENT DETERMINES THAT THE CORRECTION OF THE DEFICIEN- 19 CIES SHOULD BE EVALUATED THROUGH AN ON-SITE ASSESSMENT, THE 20 APPLICANT SHALL MAKE ALL ARRANGEMENTS AND PAY ALL COSTS FOR THE 21 ON-SITE ASSESSMENT. 22 (4) THE DEPARTMENT SHALL DETERMINE WHETHER TO DENY RENEWAL 23 OF ACCREDITATION AFTER THE LABORATORY HAS AN OPPORTUNITY FOR AN 24 EVIDENTIARY HEARING IN A CONTESTED CASE PROCEEDING UNDER THE 25 ADMINISTRATIVE PROCEDURES ACT OF 1969, 1969 PA 306, MCL 24.201 TO 26 24.328. 00084'99 29 1 SEC. 20514. (1) ACCREDITATION REMAINS IN EFFECT UNTIL 1 OF 2 THE FOLLOWING OCCURS: 3 (A) ACCREDITATION IS REVOKED BY THE DEPARTMENT. 4 (B) ACCREDITATION IS SURRENDERED BY THE ACCREDITED 5 LABORATORY. 6 (C) THE ACCREDITATION PERIOD EXPIRES, UNLESS THE LABORATORY 7 FILES A COMPLETE APPLICATION FOR RENEWAL NOT LESS THAN 60 DAYS 8 BEFORE THE EXPIRATION OF THE ACCREDITATION. 9 (2) THE DEPARTMENT SHALL REVOKE ACCREDITATION FOR CATEGORIES 10 OR ANALYTES IF ANY OF THE FOLLOWING OCCUR: 11 (A) FAILURE TO PARTICIPATE IN PT FOR ANY CATEGORY, PARAME- 12 TER, ANALYTE, OR METHOD FOR WHICH THE LABORATORY IS ACCREDITED 13 AND FOR WHICH A PT PROGRAM EXISTS, AS DETERMINED BY THE 14 DEPARTMENT. 15 (B) TWO CONSECUTIVE UNACCEPTABLE PT RESULTS. 16 (C) SUBMISSION OF PT RESULTS GENERATED BY ANOTHER 17 LABORATORY. 18 (D) FAILURE OF AN ACCREDITED LABORATORY TO REPORT TO THE 19 DEPARTMENT RECEIPT OF PT SAMPLES FROM ANOTHER LABORATORY. 20 (E) IF ACCREDITATION WAS GAINED THROUGH A RECIPROCITY AGREE- 21 MENT WITH ANOTHER STATE AGENCY, WITHDRAWAL, REVOCATION, OR OTHER 22 LOSS OF ACCREDITATION BY THE LABORATORY OR THE ORIGINAL ACCREDIT- 23 ING STATE AGENCY. 24 (F) MISREPRESENTATION OF ANY MATERIAL FACT PERTINENT TO 25 RECEIVING ACCREDITATION. 26 (G) MISREPRESENTATION OF THE CATEGORIES, PARAMETERS, 27 ANALYTES, OR METHODS FOR WHICH THE LABORATORY IS ACCREDITED. 00084'99 30 1 (H) DENIAL OF ENTRY TO THE DEPARTMENT FOR PURPOSES OF 2 LABORATORY INSPECTION OR ON-SITE ASSESSMENT. 3 (I) FALSIFICATION OF ANY REPORT OF OR RELATING TO A LABORA- 4 TORY ANALYSIS. 5 (J) AN UNACCEPTABLE ON-SITE ASSESSMENT, SUBJECT TO THE 6 REQUIREMENTS OF SECTION 20509. 7 (K) FAILURE TO PAY THE APPROPRIATE ACCREDITATION FEES. 8 (3) REVOCATION OF ACCREDITATION SHALL OCCUR ONLY FOR SPE- 9 CIFIC CATEGORIES, PARAMETERS, ANALYTES, OR METHODS IF UNSATISFAC- 10 TORY LABORATORY PERFORMANCE, PRACTICES, OR ACTIONS ARE RELATED 11 ONLY TO THOSE CATEGORIES, PARAMETERS, ANALYTES, OR METHODS. 12 (4) A LABORATORY WHOSE ACCREDITATION HAS BEEN REVOKED IS NOT 13 ELIGIBLE TO REAPPLY FOR ACCREDITATION UNTIL 6 MONTHS AFTER THE 14 DATE ON WHICH ACCREDITATION WAS REVOKED. 15 (5) THE DEPARTMENT SHALL DETERMINE WHETHER TO REVOKE ACCRED- 16 ITATION AFTER THE LABORATORY HAS AN OPPORTUNITY FOR AN EVIDEN- 17 TIARY HEARING IN A CONTESTED CASE PROCEEDING UNDER THE ADMINIS- 18 TRATIVE PROCEDURES ACT OF 1969, 1969 PA 306, MCL 24.201 TO 19 24.328. 20 SEC. 20515. (1) TO DETERMINE THE ABILITY OF AN ACCREDITED 21 LABORATORY TO PRODUCE VALID ANALYTICAL RESULTS, OR TO EVALUATE 22 THE VALIDITY OF ANY PREVIOUSLY REPORTED ANALYTICAL RESULTS, OR TO 23 EVALUATE COMPLIANCE WITH THE REQUIREMENTS OF THIS PART OR RULES 24 PROMULGATED UNDER THIS PART, THE DEPARTMENT OR THE ON-SITE 25 ASSESSMENT CONTRACTOR MAY REQUIRE THE LABORATORY DIRECTOR TO FUR- 26 NISH INFORMATION THAT THE LABORATORY IS REQUIRED TO MAINTAIN AS 27 SPECIFIED IN THIS PART OR IN RULES PROMULGATED UNDER THIS PART 00084'99 31 1 AND ANY SUPPORTING INFORMATION. PART 148 IS SUBJECT TO THE 2 REQUIREMENTS OF THIS SECTION. PRIVILEGE AND PROTECTION FROM DIS- 3 CLOSURE DO NOT APPLY TO INFORMATION REQUIRED TO BE REPORTED TO 4 THE DEPARTMENT UNDER THIS SUBSECTION. 5 (2) A PERSON REQUIRED TO FURNISH INFORMATION UNDER SUBSEC- 6 TION (1) SHALL AT THE OPTION OF THE DEPARTMENT DO EITHER OF THE 7 FOLLOWING: 8 (A) GRANT THE DEPARTMENT ACCESS AT ALL REASONABLE TIMES TO 9 INSPECT AND COPY THE INFORMATION. 10 (B) COPY AND FURNISH THE INFORMATION TO THE DEPARTMENT, AT 11 NO CHARGE. 12 (3) ALL INSPECTIONS AND INVESTIGATIONS UNDERTAKEN BY THE 13 DEPARTMENT SHALL BE COMPLETED WITH REASONABLE PROMPTNESS. 14 (4) IF THE DEPARTMENT IS REFUSED ENTRY OR INFORMATION UNDER 15 SUBSECTION (2), FOR THE PURPOSES OF ENFORCING THE INFORMATION 16 GATHERING AND ENTRY AUTHORITY PROVIDED IN THIS SECTION, THE 17 ATTORNEY GENERAL MAY DO 1 OR MORE OF THE FOLLOWING: 18 (A) PETITION THE COURT OF APPROPRIATE JURISDICTION FOR A 19 WARRANT AUTHORIZING ACCESS TO THE LABORATORY OR LABORATORY 20 RECORDS PURSUANT TO THIS SECTION. 21 (B) COMMENCE A CIVIL ACTION TO COMPEL COMPLIANCE WITH A 22 REQUEST FOR INFORMATION OR ENTRY PURSUANT TO THIS SECTION, TO 23 AUTHORIZE INFORMATION GATHERING AND ENTRY PROVIDED FOR IN THIS 24 SECTION, AND TO ENJOIN INTERFERENCE WITH THE EXERCISE OF AUTHOR- 25 ITY PROVIDED IN THIS SECTION. 00084'99 32 1 (C) SEEK CIVIL SANCTIONS ON BEHALF OF THE STATE, AS 2 SPECIFIED IN SECTION 20516, FOR FAILURE TO COMPLY WITH AN 3 INFORMATION OR ACCESS REQUEST. 4 (5) INFORMATION OBTAINED BY THE DEPARTMENT UNDER SUBSECTION 5 (1) OR (2) SHALL BE AVAILABLE TO THE PUBLIC TO THE EXTENT PRO- 6 VIDED BY THE FREEDOM OF INFORMATION ACT, 1976 PA 442, MCL 15.231 7 TO 15.246. THE PROVIDER OF INFORMATION UNDER SUBSECTION (1) OR 8 (2) MAY DESIGNATE THE INFORMATION THAT THE PROVIDER BELIEVES TO 9 BE ENTITLED TO PROTECTION AS INFORMATION OF A PERSONAL NATURE 10 UNDER SECTION 13 OF THE FREEDOM OF INFORMATION ACT, 1976 PA 442, 11 MCL 15.243. SUCH SPECIFICALLY DESIGNATED INFORMATION MUST BE 12 SUBMITTED SEPARATELY FROM OTHER INFORMATION REQUIRED TO BE PRO- 13 VIDED UNDER THIS SECTION. A DETERMINATION OF WHETHER TO GRANT AN 14 EXEMPTION FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT, 15 1976 PA 442, MCL 15.231 TO 15.246, SHALL THEN BE MADE BY THE 16 DEPARTMENT. 17 (6) NOTWITHSTANDING SUBSECTION (5), THE FOLLOWING INFORMA- 18 TION OBTAINED BY THE DEPARTMENT AS REQUIRED BY THIS SECTION SHALL 19 BE AVAILABLE TO THE PUBLIC: 20 (A) ALL APPLICATION INFORMATION SUBMITTED TO THE 21 DEPARTMENT. 22 (B) ALL LABORATORY FINAL RESULTS REQUIRED TO BE REPORTED TO 23 THE DEPARTMENT. 24 (C) THE METHOD OR METHODS USED TO PRODUCE SUCH RESULTS. 25 (D) ALL RAW DATA, CALIBRATION DATA, AND QUALITY CONTROL DATA 26 ASSOCIATED WITH THE FINAL RESULTS REQUIRED TO BE REPORTED TO THE 27 DEPARTMENT. 00084'99 33 1 (E) THE LABORATORY QUALITY ASSURANCE MANUAL. 2 (F) ALL PT RESULTS AND PT RESULT REPORTS. 3 (G) THE SIGNED CERTIFICATION OF COMPLIANCE STATEMENT UNDER 4 SECTION 20503 AND THE SIGNED VALIDATION STATEMENT UNDER SECTION 5 20512. 6 SEC. 20516. (1) IN ADDITION TO OTHER RELIEF AUTHORIZED BY 7 LAW, THE ATTORNEY GENERAL MAY, ON BEHALF OF THE STATE, COMMENCE A 8 CIVIL ACTION AGAINST THE LABORATORY FOR 1 OR MORE OF THE 9 FOLLOWING: 10 (A) RECOVERY OF STATE INVESTIGATIVE, SAMPLING, OR ANALYTICAL 11 COSTS WHERE DATA IS UNUSABLE DUE TO 1 OR MORE OF THE FOLLOWING: 12 (i) ANALYTICAL ERRORS CAUSED BY A LABORATORY'S FAILURE TO 13 FOLLOW LABORATORY QUALITY CONTROL PROCEDURES, ANALYTICAL METHODS, 14 OR THE REQUIREMENTS OF THIS PART OR RULES PROMULGATED UNDER THIS 15 PART. 16 (ii) INADEQUATE LABORATORY RECORD KEEPING THAT PREVENTS VAL- 17 IDATION OF REPORTED RESULTS. 18 (B) ENFORCEMENT OF INFORMATION GATHERING AND ENTRY AUTHORITY 19 UNDER SECTION 20515. 20 (2) EXCEPT AS OTHERWISE PROVIDED IN THIS PART, AN ACTION 21 BROUGHT UNDER THIS PART MAY BE BROUGHT IN THE CIRCUIT COURT FOR 22 INGHAM COUNTY OR IN THE COUNTY IN WHICH THE LABORATORY IS LOCATED 23 OR HAS A PLACE OF BUSINESS OR IN WHICH THE REGISTERED OFFICE OF A 24 DEFENDANT CORPORATION IS LOCATED. 25 SEC. 20517. (1) A PERSON SHALL NOT KNOWINGLY DO ANY OF THE 26 FOLLOWING: 00084'99 34 1 (A) MAKE A FALSE STATEMENT OR REPRESENTATION IN ANY 2 APPLICATION, RECORD, REPORT, OR OTHER DOCUMENT FILED WITH THE 3 DEPARTMENT OR REQUIRED TO BE MAINTAINED UNDER THIS PART OR THE 4 RULES PROMULGATED UNDER THIS PART. 5 (B) DESTROY, ALTER, OR CONCEAL ANY RECORD, REPORT, OR DOCU- 6 MENT REQUIRED TO BE MAINTAINED UNDER THIS PART OR THE RULES 7 PROMULGATED UNDER THIS PART. 8 (C) AID, ABET, PERMIT, OR FACILITATE THE SUBMISSION OF ANY 9 FALSE STATEMENT OR REPRESENTATION UNDER THIS PART TO THE STATE OR 10 ANY AGENCY OF THE STATE BY ANY OTHER PARTY. 11 (D) REPRESENT THAT THE LABORATORY IS ACCREDITED UNDER THIS 12 PART IN AN AREA IN WHICH IT IS NOT ACCREDITED. 13 (2) A PERSON WHO VIOLATES SUBSECTION (1) IS GUILTY OF A 14 FELONY PUNISHABLE AS FOLLOWS FOR EACH VIOLATION: 15 (A) EXCEPT AS PROVIDED IN SUBDIVISIONS (B) AND (C), BY 16 IMPRISONMENT FOR NOT MORE THAN 2 YEARS OR A FINE OF NOT LESS THAN 17 $10,000.00 OR MORE THAN $25,000.00, OR BOTH. 18 (B) EXCEPT AS PROVIDED IN SUBDIVISION (C), IF A CONVICTION 19 UNDER SUBSECTION (1) IS FOR A VIOLATION COMMITTED AFTER A FIRST 20 CONVICTION, BY IMPRISONMENT FOR NOT MORE THAN 5 YEARS OR A FINE 21 OF NOT LESS THAN $50,000.00, OR BOTH. 22 (C) UPON A FINDING BY THE COURT THAT THE ACTION OF A 23 DEFENDANT CONVICTED UNDER SUBSECTION (1) POSES OR POSED A SUB- 24 STANTIAL ENDANGERMENT TO PUBLIC HEALTH, SAFETY, OR WELFARE, BY 25 IMPRISONMENT FOR NOT MORE THAN 5 YEARS OR A FINE OF NOT LESS THAN 26 $100,000.00 OR MORE THAN $1,000,000.00, OR BOTH. 00084'99 35 1 (3) TO FIND A DEFENDANT CRIMINALLY LIABLE FOR SUBSTANTIAL 2 ENDANGERMENT UNDER SUBSECTION (2)(C), THE COURT SHALL DETERMINE 3 THAT THE DEFENDANT KNOWINGLY OR RECKLESSLY ACTED IN SUCH A MANNER 4 AS TO CAUSE A DANGER OF DEATH OR SERIOUS BODILY INJURY AND THAT 5 EITHER OF THE FOLLOWING APPLIES: 6 (A) THE DEFENDANT HAD AN ACTUAL AWARENESS, BELIEF, OR UNDER- 7 STANDING THAT HIS OR HER CONDUCT WOULD CAUSE A SUBSTANTIAL DANGER 8 OF DEATH OR SERIOUS BODILY INJURY. 9 (B) THE DEFENDANT ACTED IN GROSS DISREGARD OF THE STANDARD 10 OF CARE THAT A REASONABLE PERSON WOULD OBSERVE IN SIMILAR 11 CIRCUMSTANCES. 12 SEC. 20518. (1) PRIOR TO REQUIRING ACCREDITATION, THE 13 DEPARTMENT SHALL PROMULGATE RULES PERTAINING TO THE ACCREDITATION 14 PROGRAM TO SPECIFY ALL OF THE FOLLOWING: 15 (A) THE LABORATORIES OR REGULATORY PROGRAMS THAT ARE SUBJECT 16 TO ACCREDITATION. 17 (B) ACCREDITATION PROCEDURES. 18 (C) THE ACCREDITATION CATEGORIES FOR WHICH ACCREDITATION IS 19 AVAILABLE AND THE ANALYTES, PARAMETERS, AND ANALYTICAL METHODS TO 20 BE INCLUDED IN EACH ACCREDITATION CATEGORY. 21 (D) THE LABORATORY REQUIREMENTS FOR ESTABLISHING AND MAIN- 22 TAINING ACCEPTABLE LABORATORY QUALITY SYSTEMS. THESE RULES MAY 23 SPECIFY REQUIREMENTS FOR ALL OF THE FOLLOWING: 24 (i) LABORATORY ORGANIZATION AND MANAGEMENT. 25 (ii) ESTABLISHMENT OF AUDITS, ESSENTIAL QUALITY CONTROLS, 26 AND DATA VERIFICATION. 00084'99 36 1 (iii) PERSONNEL. 2 (iv) PHYSICAL FACILITIES. 3 (v) EQUIPMENT AND REFERENCE MATERIALS. 4 (vi) MEASUREMENT TRACEABILITY OF STANDARDS AND REGENTS. 5 (vii) METHOD CALIBRATION AND PERFORMANCE. 6 (viii) SAMPLE HANDLING, ACCEPTANCE, RECEIPT, AND TRACKING. 7 (ix) RECORD MAKING AND RETENTION. 8 (x) LABORATORY REPORT CONTENT. 9 (E) QUALIFICATIONS FOR ON-SITE ASSESSMENT CONTRACTORS. 10 (F) QUALIFICATIONS FOR PT PROGRAMS. 11 (G) OTHER ASPECTS OF THE ACCREDITATION PROGRAM NECESSARY TO 12 IMPLEMENT THIS PART. 13 (2) THE DEPARTMENT MAY PROMULGATE RULES TO SPECIFY ANY OF 14 THE FOLLOWING: 15 (A) THE PROCEDURES AND CONDITIONS UNDER WHICH THE DEPARTMENT 16 MAY ENTER INTO AGREEMENTS WITH THE GOVERNMENT OF ANY STATE OR 17 THIRD PARTY NONGOVERNMENTAL ENTITY FOR THE PURPOSE OF RECOGNIZING 18 THE ACCREDITATION OF OUT-OF-STATE LABORATORIES. 19 (B) THE TYPE AND AMOUNT OF DOCUMENTATION TO BE SUBMITTED IN 20 SUPPORT OF ALTERNATIVE TEST PROCEDURE APPLICATIONS AND THE REVIEW 21 PROCEDURE, APPLICATION PROCESS, AND APPLICABILITY OF ALTERNATIVE 22 TEST PROCEDURES TO SPECIFIC REGULATORY PROGRAMS. 23 (C) PROCEDURES FOR ESTABLISHING PT PERFORMANCE LIMITS. 24 SEC. 20519. DURING JANUARY OF 2000 AND EVERY EVEN NUMBERED 25 YEAR THEREAFTER, THE DEPARTMENT SHALL REPORT TO THE SENATE AND 26 HOUSE LEGISLATIVE COMMITTEES PRIMARILY RESPONSIBLE FOR 27 ENVIRONMENTAL PROTECTION LEGISLATION WHETHER A NATIONAL 00084'99 37 1 LABORATORY PROGRAM HAS BEEN INSTITUTED BY WHICH LABORATORIES ARE 2 RECOGNIZED AS MEETING CERTAIN QUALIFICATIONS OR STANDARDS. IF 3 SUCH A PROGRAM HAS BEEN INSTITUTED, THE DEPARTMENT SHALL INCLUDE 4 IN THE REPORT ITS RECOMMENDATIONS AS TO WHETHER THIS PART SHOULD 5 BE AMENDED OR REPEALED. 00084'99 Final page. TMV