Mountain States Medical Group Pediatrics

Summary Statement of Deficiencies D0000 During a recertification survey completed on March 4, 2026, the laboratory was found out of compliance with the following condition: 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), College of American Pathology (CAP) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that three of six testing personnel (TP) who performed hematology patient testing also participated in proficiency testing in 2024 and 2025. The findings include: 1. An observation of the laboratory on 03.04.2026 at 9:00 a.m. revealed a Beckman Coulter DxH520 hematology analyzer (Serial Number: BG080462) used for complete blood count (CBC) patient testing. 2. A review of the FORM CMS-209 revealed a total of six testing personnel (TP1, TP2, TP3, TP4, TP5, and TP6) who perform moderately complex CBC patient testing. 3. A review of the laboratory's CAP PT attestation statements revealed that TP2, TP3, and TP4 did not participate in any hematology PT events (0 of 6 reviewed) in 2024 and 2025. 4. An interview with the technical consultant and laboratory lead (TP1) on 03.04.2026 at 11: 00 a.m. confirmed the above survey findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the submitted Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), laboratory's procedure, personnel records, and staff interviews, revealed the laboratory's policy failed to include assessment of the regulatory responsibilities for the technical consultant (TC) and semi-annual competency evaluation for testing personnel (TP) as required in Subpart M of the State Operations Manual (SOM) Appendix C, and failed to have documentation of TC competency for 2024 and 2025 and semi-annual competency for one of six TP on the survey date (03.04.2026). Findings included: 1. A review of the submitted FORM CMS-209 form listed one TC and six TP for moderate complexity testing. 2. A review of the laboratory's Quality Assurance Plan procedure revealed the policy failed to include competency assessment for the TC and semi-annual competency assessments for TP performing moderate complexity testing. 3. A review of laboratory personnel records revealed the following: -No documented TC competency assessment for 2024 and 2025 as listed on FORM CMS-209 -No documented semi-annual competency assessment for TP4 as listed on FORM CMS- 209 4. An interview with the laboratory director, technical consultant, and laboratory lead (TP1) on 03.04.2026 at 12:30 p.m. confirmed the above survey findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory procedure manual, calibration verification records, and staff interviews, the laboratory failed to follow its written procedure for the frequency of hematology analyzer calibration verification in 2025. The previous survey on 03.14.2024 included this citation: it was determined that the laboratory failed to maintain compliance at the recertification survey on 03.04.2026. The findings include: 1. An observation of the laboratory on 03.04.2026 at 9:00 a.m. revealed a Beckman Coulter DxH520 hematology analyzer (Serial Number: BG080462) used for complete blood count (CBC) patient testing. 2. A review of the laboratory's "Quality Control Program" procedure revealed, "Calibration is performed at least every six months or more frequently if specified by the manufacturer." 3. A review of laboratory calibration verification records revealed the laboratory failed to perform hematology analyzer calibration verification every six months in 2025 (calibrations performed on 08.13.2024 and 07.18.2025). 4. An interview with the laboratory director, technical consultant, and laboratory lead (TP1) on 03.04.2026 at 12:30 p.m. confirmed the above survey findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) -- 2 of 4 -- (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's control package insert, review of laboratory policy, and staff interviews, the laboratory failed to label three of three control vials used for performing quality control on the Beckman Coulter DxH520 hematology analyzer with a revised expiration date on the survey date (03.04.2026). The findings include: 1. An observation of the laboratory on 03.04.2026 at 9:00 a.m. revealed a Beckman Coulter DxH520 hematology analyzer (Serial Number: BG080462) used for complete blood count (CBC) patient testing. Observation also revealed three levels of DxH500 Series hematology controls (lot numbers: abnormal low-352618111, normal-362618112, abnormal high-372618113) that lacked revised expiration dates. 2. A review of the manufacturer's control package insert revealed that "16* Open Vial Days, *Assumes that the Instructions for Use section of the Consumable IFU/Setting Sheet is performed a maximum of 16 times within 16 days, provided they are handled properly." 3. A review of the laboratory's "Quality Control Program" procedure revealed, "Once reagents are opened, the date opened, expiration date and initials of the person must be placed on the label." 4. An interview with the laboratory director, technical consultant, and laboratory lead (TP1) on 03.04.2026 at 12:30 p.m. confirmed the above survey findings. Word key: IFU = Instructions for Use D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), review of testing personnel (TP) records, and staff interviews, three of six TP did not qualify to perform moderately complex Complete Blood Count (CBC) patient testing due to a lack of documentation of the highest level of education for three of three new TP since the last survey. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory -- 3 of 4 -- science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), review of testing personnel (TP) records, and staff interviews, three of six TP did not qualify to perform moderately complex Complete Blood Count (CBC) patient testing due to a lack of documentation of the highest level of education for three of three new TP since the last survey. The findings include: 1. A review of the FORM CMS-209 revealed TP4, TP5, and TP6 listed as performing moderately complex CBC patient testing. 2. A review of TP records revealed three new TP (TP4, TP5, and TP6) since the last survey, with no documentation of the highest level of education. 3. An interview with the office manager on 03.04.2026 at 11:29 a.m. and subsequent interviews with the laboratory director, technical consultant, and laboratory lead (TP1) on 03.04.2026 at 12:30 p.m. confirmed the above survey findings. -- 4 of 4 --

Summary Statement of Deficiencies 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 Centers for Medicare and Medicaid Services CASPER Report 155 (CMS 155) and the laboratory's 2024 College of American Pathologists (CAP) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events for the White Blood Cell Differential (CELL-ID) and Hemoglobin (HGB) analytes (Refer to D2130) and the Hematology specialty (Refer to D2131) resulting in initial unsuccessful PT performance. D2130 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS 155 and the laboratory's CAP PT evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive test events for the White Blood Cell Differential (CELL-ID) and Hemoglobin (HGB) analytes, resulting in initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory scores: -2024 Event one: 0% for CELL-ID and HGB -2024 Event two: 0% for CELL-ID and HGB 2. A review of the laboratory's 2024 CAP Hematology PT evaluation reports revealed the following unsatisfactory scores: -2024 Event one: 0% for CELL-ID and HGB -2024 Event two: 0% for CELL-ID and HGB D2131 HEMATOLOGY CFR(s): 493.851(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 a desk review of the CMS 155 and the laboratory's CAP PT evaluation reports, the laboratory failed to achieve satisfactory performance for the overall specialty of Hematology in two consecutive PT events in 2024. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory Hematology PT event scores: -2024 Event one: 33% -2024 Event two: 53% 2. A review of the laboratory's 2024 CAP Hematology PT evaluation reports revealed the following unsatisfactory Hematology event scores: -2024 Event one: 33% -2024 Event two: 53% -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and an interview with the technical consultant, the laboratory testing personnel and/or lab director/designee failed to sign three of four attestation statements from 2023 and 2024. The findings include: 1. A review of the laboratory's 2023 and 2024 CAP PT attestation statements revealed the following: - The testing personnel failed to sign Hematology 2023 events two and three. - The lab director/designee failed to sign Hematology 2024 event one. 2. An interview with the technical consultant on 03.12.2024 at 12:45 p.m. confirmed the above survey findings. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and an interview with the technical consultant, the laboratory failed to retain the attestation statement and performance evaluation for two years for one of three PT events reviewed from 2023. The findings include: 1. A review of the laboratory's CAP PT records revealed the laboratory did not retain the attestation statement and performance evaluation for hematology 2023 event one. 2. An interview with the technical consultant on 03.12.2024 at 12:45 p.m. confirmed the laboratory failed to retain the PT attestation statement and performance evaluation for at least two years for one of three PT events reviewed from 2023. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: CITATION ONE: Based on observation of the laboratory, review of laboratory procedure manual, review of instrument calibration records, and interview with the technical consultant, the laboratory failed to follow their written policy for hematology analyzer calibration frequency in 2023. The findings include: 1. Observation of the laboratory on 03.12.2024 at 9:00 a.m. revealed a Beckman Coulter DxH520 hematology analyzer (Serial Number: 8368830) in use for patient Complete Blood Count (CBC) testing. 2. A review of the laboratory's quality control program procedure revealed the following statement, "Calibration is performed at least every six months or more frequently if specified by manufacturer." 3. A review of hematology analyzer calibration records revealed analyzer calibration was not performed every six months in 2023. 4. Interview on 03.12.2024 at 12:45 p.m. with the technical consultant confirmed the above survey findings. CITATION TWO: Based on observation of the laboratory, review of laboratory procedure manual, record request, and interview with the technical consultant, the laboratory failed to follow their written policy for printing and reviewing hematology Levy-Jennings charts in 2023. The findings include: 1. Observation of the laboratory on 03.12.2024 at 9:00 a.m. revealed a Beckman Coulter DxH520 hematology analyzer (Serial Number: 8368830) in use for patient Complete Blood Count (CBC) testing. 2. A review of the laboratory's quality control monitoring procedure revealed that Levy- Jennings charts for hematology are printed and reviewed monthly. 3. A request for monthly Levy-Jennings charts for hematology revealed no Levy-Jennings charts available for surveyor review from January 2023 through December 2023. 4. Interview on 03.12.2024 at 12:45 p.m. with the technical consultant confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: =================================== Based on review of the laboratory's College of Amercian Pathologists (CAP) proficiency testing (PT) records and interview with the lead testing person, it was determined the testing personnel and the laboratory director failed to sign the attestation sheets for three of six Hematology PT events for 2020, 2021, and 2022. The findings include: 1. Review of the laboratory's PT records revealed that attestation sheets were not signed by testing personnel or laboratory director for three of six Hematology PT events (2020 event three; 2021 event one; 2022 event two). 2. Interview with the lead testing person on November 7, 2022 at 12:00 pm confirmed that attestation sheets were not signed by testing personnel and laboratory director for three of six Hematology PT events for 2020, 2021, and 2022. ================================== D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: ================================== Based on review of employee Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- personnel records for 2020, 2021 and 2022 and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for testing personnel number one listed on the Center for Medicare and Medicaid Services Personnel Report (CMS-209) for Hematology for 2021. The findings include: 1) Review of employee personnel records for 2020, 2021 and 2022 failed to include documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills for testing personnel number one on the CMS- 209 for Hematology for 2021. 2) An interview with the lead testing person on November 7, 2022 at 12:00 p.m. confirmed testing person number one listed on the CMS 209 was not evaluated using the six criteria for competency required by CMS for 2021 for Hematology. ================================== D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: =================================== Based on review of competency assessment for the technical consultant and interview with the lead testing person, determined the Laboratory Director failed to evaluate the technical consultant listed on the CMS Form 209 in 2020, 2021 and 2022. The findings include: 1. Review of 2020, 2021 and 2022 competency assessments revealed no documentation of competency assessment for technical consultant for 2020, 2021 and 2022. 2. Interview with the lead testing person on November 7, 2022 at 12:00 P.M. confirmed the above findings. ===================================== -- 2 of 2 --

Summary Statement of Deficiencies 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: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the automated White Blood Cell (WBC) differential, resulting in the first unsuccessful Proficiency Testing (PT) occurrence for the automated WBC Differential analyte (Refer to D2130). =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2020 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the automated White Blood Cell (WBC) Differential in the 2nd and 3rd events of 2020, resulting in the first unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed the score for the automated WBC Differential for the 2nd event of 2020 was 40% and for the 3rd event of 2020 was 0%. 2. A review of the laboratory's 2020 API Proficiency Testing records revealed the 2nd event had unacceptable performance for Basophils, Eosinophils and Neutrophils resulting in a 0% score for a total event score of 40% for the WBC differential. 3. A review of the laboratory's 2020 API Proficiency Testing records revealed the 3rd event had unacceptable performance for Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils resulting in a 0% score for a total event score of 0% for the WBC Differential, resulting in the first unsuccessful PT occurrence. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D0000 ____________________________________ $493.51 Notification requirements for laboratories issued a Certificate of Compliance (Rev.140, Issued: 05/29/15, Effective: 05/29/15, Implementation: 05/29/15). Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location (4) Director; or (Technical Supervisor (laboratories performing high complexity only). ____________________________________ Based on information filled out on the Disclosure of Ownership and Control Interest Statement-TN Clinical Laboratory Improvement Amendments (PH-4150) form and an interview with the Medical Laboratory Technician, it was determined the laboratory had changed ownership and name in July 2018 but had failed to notify HHS. The findings include: 1. Information documented on the Disclosure of Ownership and Control Interest Statement (form PH- 4150) disclosed new ownership and new name of practice. 2. An interview at approximately 1:30 p.m. on December 12, 2019 with the Medical Laboratory Technicial confirmed the laboratory had changed ownership and name of practice in July 2018 and had not informed HHS. ====================================== D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. 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 -- This STANDARD is not met as evidenced by: =================================== Based on review of Proficiency Testing (PT) documents for 2018 and 2019 and upon interview with the MLT (Medical Laboratory Technician), it was determined the laboratory failed to save all PT documents for a minimum of two years. The findings include: 1. A review of 2018 and 2019 PT documents disclosed: a. Event FH2-B 2018 Hematology: No testing results and no attestation sheet available for Complete Blood Count (CBC) PT; b. Event VR3-B 2018 Infectious Disease: No documentation of test results or attestation sheet available for Mycoplasma; c. Event FH2-A 2019 Hematology: Attestation Sheet not signed by Laboratory Director or Testing Personnel; d. Event FH2-B 2019 Hematology: No attestation sheet available for CBC testing. e. Event VR3-A 2019 Infectious Disease: No documentation of test results, no attestation sheet and no PT program evaluation available for Mycoplasma. 2. An interview with the MLT at approximately 1:30 p.m. on December 12, 2019 confirmed that all attestation sheets and test results for CBC and Mycoplasma Proficiency Testing had not been saved for the two year period. ==================================== D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: =================================== Based on review of the laboratory proficiency testing records, lack of laboratory review and interview with the MLT, the laboratory failed to evaluate non-graded proficiency testing scores for Mycoplasma in 2018 and 2019. The findings include: 1. Review of the laboratory proficiency testing records for 2018 and 2019 revealed non-graded scores for Mycoplasma with no evaluation of Mycoplasma results by the laboratory to ensure accuracy. 2. Interview at approximately 1:30 p.m. on December 12, 2019 with the MLT confirmed the laboratory failed to evaluate the accuracy of non-graded proficiency testing scores for Mycoplasma in 2018 and 2019. ==================================== D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: =================================== Based on observation of Mycoplasma test kit in refrigerator at approximately 9:30 a.m. on December 12, 2019, lack of IQCP (Individualized Quality Control Plan) for Mycoplasma testing upon review of procedure manual, review of patient testing and QC logs and upon interview with the MLT, it was determined the laboratory failed to have an equivalent quality control procedure for testing control materials less than each day of patient testing for Mycoplasma during 2018 and 2019. The findings include: 1. Observed Mycoplasma test kit in refrigerator at approximately 9:30 a.m. on December 12, 2019 during laboratory survey tour. 2. A review of the procedure manual disclosed no IQCP procedure for Mycoplasma testing. 3. A review of the patient testing and QC logs for Mycoplasma disclosed Quality Control performed once monthly and upon new kit lot number. 3. An interview at approximately 1:30 p.m. on December 12, 2019 with the MLT confirmed there was no IQCP procedure in place for the Mycoplasma test for the two year period. ==================================== D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: =================================== Based on review of procedure for verifying CBC (Complete Blood Count) controls, lack of new lot number verification for CBC control materials and interview with the MLT, it was determined the laboratory failed to follow procedure for verifying the acceptable ranges of each new lot of CBC control materials prior to use for 2018 and 2019. The finding include: 1. A procedure review stated that verification of new CBC controls for acceptability is to be performed before using on patient testing. 2. There was no documentation for verification of new lot numbers of CBC control materials for 2018 and 2019. 2. An interview at 1:30 p.m. on December 12, 2019 with the MLT confirmed that new lot number verification of CBC control materials had not been performed for the two year period. ==================================== D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. -- 3 of 4 -- This STANDARD is not met as evidenced by: =================================== Based on review of the laboratory's Quality Assessment (QA) policy, lack of director review of Quality Control (QC) results for CBC's (Complete Blood Counts) and Mycoplasma testing and upon interview with the laboratory MLT, it was determined the laboratory director failed to follow policy for monthly QC review for 2018 and 2019. The findings include: 1. A review of the QA policy stated that QC records are to be reviewed monthly by Laboratory Director or designee. 2. Upon review of CBC and Mycoplasma QC records for 2018 and 2019, it was disclosed there was no documentation of director reivew. 3. An interview at approximately 1:30 p.m. on December 12, 2019 with the MLT confirmed the laboratory director failed to review CBC and Mycoplasma Quality Control results for the two year period. ==================================== D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: =================================== Based on ten testing personnel listed on the CMS (Centers For Medicare & Medicaid Services) Laboratory Personnel Report Form 209, review of the Technical Consultant's signed job description and upon interview with the MLT, it was determined the Technical Consultant failed to evaluate 10 of 10 testing personnel for 2018 and 2019 for CBC and Mycoplasma competency. The findings include: 1. Ten testing personnel (TP) listed on the CMS form 209 failed to have documented training and competency as listed for 2018 and 2019: a. TP #1-hire date 7/10/17: no training, 6 month or annual competencies documented; b. TP #2-hire date 9/3/19: no training documented; c. TP #3-hire date 6 /24/19: no training documented; d. TP #4-hire date 5/30/17: no annual competencies documented for 2018 or 2019; e. TP #5-hire date 2/14/11: no annual competencies documented for 2018 or 2019; f. TP #6-hire date 9/22/15: no annual competencies documented for 2018 or 2019; g. TP #7-hire date 10/01/13: no annual competencies documented for 2018 or 2019; h. TP #8-hire date 3/2019: no training or 6 month competency documented; i. TP #9-hire date 2/14/13: no annual competencies documented for 2018 or 2019; j. TP #10-hire date 2/11/17: no annual competencies documented for 2018 or 2019. 2. Review of Technical Consultant's job description stated to evaluate the competency of all testing personnel and asure the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. Evaluate at least semi-annually during the first year and then annually after that. 3. An interview at approximately 1:30 p.m. on December 12, 2019 with the MLT confirmed the Technical Consultant had not performed training and competencies as listed for the ten testing personnel for 2018 and 2019. ===================================== -- 4 of 4 --