Mn Clinical Laboratory

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certificate and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2024-2 and 2024-3), the laboratory failed to successfully participate in a proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Toxicology and analytes: Carbamazepine, Digoxin, Lithium, Phenobarbital, Phenytoin, and Valproic Acid resulting in unsuccessful performances. Refer to D2118 and D2119. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation program report, the laboratory failed to achieve satisfactory performance for two consecutive events (2024 second & third testing events) for the following analytes: The findings include: 1. Carbamazepine - 0% 2024 second testing event, Carbamazepine - 0% 2024 third testing event. 2. Digoxin - 0% 2024 second testing event, Digoxin - 0% 2024 third testing event. 3. Lithium - 0% 2024 second testing event, Lithium - 0% 2024 third testing event. 4. Phenobarbital - 0% 2024 second testing event, Phenobarbital - 0% 2024 third testing event. 5. Phenytoin - 0% 2024 second testing event, Phenytoin 0% 2024 third testing event. 6. Valproic Acid - 0% 2024 second testing event, Valproic Acit - 0% 2024 third testing event. AAB- Medical Laboratory Evaluation confirmed the above findings. D2119 TOXICOLOGY CFR(s): 493.845(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation reports, the laboratory failed to achieve satisfactory performance for consecutive proficiency events in 2024 for specialty Toxicology: The laboratory received the following scores: 1. The laboratory received the following scores: 0% for the 2024-2 Toxicology, 0% on the 2024-3 Toxicology. A review of the 2024 proficiency testing scores from AAB-Medical Laboratory Evaluation confirms the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2024-2 and 2024-3 proficiency events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2024-2 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2118 and D2119. -- 3 of 3 --

Summary Statement of Deficiencies D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the AAB-Medical Laboratory Evaluation (AAB) and the College of American Pathologists (CAP) Proficiency Testing (PT) records and interview with the laboratory technical supervisor (TS) and laboratory director (LD); it was determined that the laboratory failed to attain a score of least 80 percent of acceptable responses for Rubella and Anti-HIV. The findings included: 1. Based on review of PT records for the third event of 2021 (Q3-2021) AAB reported an unsatisfactory score of 60% for Rubella PT testing. 2. Based on review of PT records for Q3-2021, CAP reported an unsatisfactory score of 20% for Anti-HIV testing. 3. Based on the laboratory's testing declaration at the time of the survey on April 28, 2023, the laboratory reported approximately 51,936 General Immunology tests results which include both Rubella and Anti-HIV analytes during the time the laboratory had unsatisfactory PT testing scores. 4. The TS affirmed that the laboratory received the above unsatisfactory General Immunology Rubella and HIV analytes PT scores D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the AAB-Medical Laboratory Evaluation (AAB) proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- testing (PT) records, five (5) randomly chosen patient results, and interview with the technical supervisor; it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Routine Chemistry analyte CK, Total. The finding included: 1. Based on review of PT records for the Q3-2022, AAB reported an unsatisfactory score report of 60% for CK, Total analyte. 2. Based on the laboratory testing declaration submitted at the time of the survey on 4/28/2023, the laboratory analyzed and reported approximately 1,141.062 Routine Chemistry tests including CK, Total during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS affirmed on 4/28/2023 at approximately 11:45 a.m. that the laboratory received the above unsatisfactory proficiency testing scores. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's SARS-CoV-2 RNA (COVID-19) Polymerase Chain Reaction (PCR) testing, and interviews with the laboratory's technical supervisor and testing personnel (TP) on April 28, 2023 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the PCR procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, master mix and reagents preparation, amplification, and product detection. The findings included: 1. The laboratory performed PCR testing for the presumptive detection of SARS-CoV-2 using automated and manual methods for preparation of the master-mixes, controls and reagents, and addition of template. 2. During the laboratory tour on April 28, 2023, at approximately 3:30 p.m. the surveyor observed that processing of the specimens, preparation of reagents, and sample template addition were all performed in the same room/area without unidirectional flow. 3. The TS and TP confirmed by interview that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in a unidirectional flow area. 4. Based on laboratory records, the laboratory performed and reported approximately 3,748 SARS-CoV-2 Real Time PCR molecular diagnostic tests annually. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing (PT) records for the years of 2021, 2022, 2023 and interview with the technical supervisor (TS) on April 28, 2023 the laboratory failed to retain its PT test records for two PT events in 2021. The findings include: 1. The laboratory failed to locate PT laboratory data and testing results for Rubella and anti-HIV PT Q3-2021 provided by AAB-Medical Laboratory Evaluation and the College of American Pathologists respectively, 2. The laboratory TS affirmed on April 28, 2023, at approximately 2:30 p.m. that the -- 2 of 3 -- laboratory did not keep Q3-2021 PT results documentation for Rubella and Anti-HIV testing results. 3. The laboratory's testing declaration form, signed by the laboratory Director on 4/28/2023, stated that the laboratory performs 51,936 General Immunology samples annually including the analytes mentioned in 2. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on the surveyor's direct observations of the laboratory's SARS-CoV-2 PCR testing processes and interview with the laboratory's director, technical supervisor, and testing personnel on April 28,2023; the laboratory director failed to ensure that the physical plant and environmental conditions of the laboratory were appropriate for the PCR testing performed. Findings include: See D3005. -- 3 of 3 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) results reports, and interview with the laboratory testing personnel, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent was unsatisfactory performance. The findings included: a. The laboratory performed bacteriology and report non-growth and groth of organisms with culture identification. b. The laboratory enrolled its proficiency testing program with AAB. c. The laboratory attained an overall testing score of 75% in Culture Identification (ID) for the Q1 2020 Bacteriology PT event, which was unsatisfactory performance. d. The laboratory performed bacteriology in approximately 3711 patient samples monthly. e. The laboratory personnel affirmed (3/5/2021 @ 2:45 PM) that the laboratory attained an overall testing score of 75% for Culture Identification in the Q1 2020 Bacteriology PT event, which was unsatisfactory performance. D2109 TOXICOLOGY CFR(s): 493.845(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) results reports, and interview with the laboratory testing personnel, it was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Toxicology PT testing event is unsatisfactory analyte performance. The findings included: a. The laboratory performed Toxicology including but not limited to Phenobarbital. b. The laboratory enrolled its proficiency testing program with AAB for the Toxicology testings.. c. The laboratory attained a score of 60% for Phenbarbital in the Q1 2019 Toxicology PT event, which was unsatisfactory performance. d. The laboratory performed Phenobarbital in approximately 9 patient samples monthly. e. The laboratory personnel affirmed (3/5 /2021 @ 2:45 PM) that the laboratory attained a score of 60% for Phenobarbital in the Q1 2019 Toxicology PT event, which was unsatisfactory performance. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's daily quality control (QC) records and Levy Jennings (LJ) charts, and interview with the laboratory testing personnel, it was determined that the laboratory failed to detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance, and failed to monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. The findings included: a. The laboratory use Roche Instrument to perform and report the routine chemistry tests including but not limited to Alfa Feto Protein (AFP) and Alk. Phosphatase (ALP). b. The laboratory purchased assayed commercial QC materials and elected to use the assayed mean and standard deviation (SD) data published by the manufacturer instruction (MI), after the laboratory had verified the new batch of the MI concurrent with the laboratory's current QC results in daily run. c. A LJ chart provides cumulative quality control data information for trending or shifting in serials QC run. d. The laboratory used three levels of BioRad QC materials, Q1, Q2, and Q3, for AFP lot # 85231, 85232, and 85233, for ALP lot # 45811, 48512, and 45813. e. Review a LJ chart for AFP from 12 /01/2020 thru 01/03/2021, about 30 run data, had indicated calculated Q1 mean 29.42 (23.6 - 35.2) vs set mean 32.8 (25.8 - 39.8) ; calculated Q2 mean 116.5 (96.5 - 135.5) vs set mean 128 (102.4 - 153.6) , and calculate Q3 mean 239.7 (197.7 - 281.7) vs. set mean of 263 (211 - 315), which indicated all three levels showing negative shift from their mean setting. f. Review a LJ chart for ALP from 12/01/2020 thru 01/03/2021, about 30 run data, had indicated Q1 with calculated mean 28.9 (24.9 - 32.9), in a negative bias/shift vs set mean of 33.9 (26.7 - 41.0) , and Q3 calculated mean 293 (257 - 329) Q3 vs set 279 (243 - 315) data, which indicated a positive bias/shift from -- 2 of 4 -- their mean setting. g. The laboratory failed to monitor and take actions for this bias shifting QC values. h. The laboratory personnel affirmed (3/5/2021 @ 1:50 PM) that the laboratory failed to monitor and take actions for this negative bias shifting. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) results reports, and interview with the laboratory testing personnel, it was determined that the laboratory director who is failed to be responsible for the overall operation and administration of the laboratory, including but are not limited to ensure that the proficiency testing samples were tested as required and be satifactory for all events. The findings included: a. The laboratory performed multiple subspecialties and spectialties tests including, but are not limited to the following: Culture Identification and Toxicology. b. The laboratory enrolled its proficiency testing programs with AAB for the Bacteriiology and Toxicology tests.. c. The laboratory attained an overall testing score of 75% for Culture Identification in the Q1 2020 Bacteriology PT event, which was unsatisfactory performance, see D-2020. c. The laboratory attained a score of 60% for Phenbarbital in the Q1 2019 Toxicology PT event, which was unsatisfactory performance see D-2109. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's daily quality control (QC) records and Levy Jennings (LJ) charts, and interview with the laboratory testing personnel, it was determined that the laboratory director failed to ensure that the quality control and quality assessment programs were established and maintained to identify failures in quality as they occur. The findings included: a. The laboratory use Roche Instrument to perform and report the routine chemistry tests results including but not limited to Alfa Feto Protein (AFP) and Alk. Phosphatase (ALP). b. The laboratory purchased assayed commercial QC materials and elected to use the assayed mean and standard deviation (SD) data published by the manufacturer instruction (MI), after the laboratory had verified the new batch of the MI mean values concurrent with the laboratory's current QC results in daily run. c. Two LJ charts, AFP and ALP between -- 3 of 4 -- 12/02/20 thru 01/03/2021 were found negative bias shifting, and the laboratory failed to take actions, see D-5441 -- 4 of 4 --