Metabolic Disease Associates Inc

Summary Statement of Deficiencies D0000 A desk review for proficiency testing results was conducted by the Pennsylvania State Agency for Metabolic Disease Associates on 08/13/2025. The laboratory was found out of compliance with the following conditions: 493.803 Condition: Successful participation. 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 CASPER 0155 report and graded results from the proficiency testing (PT) organization, American Association of Bioanalysts-Medical Laboratory 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 -- Evaluation (AAB-MLE), the laboratory failed to successfully participate in PT for Free Thyroxine (FT4) . The laboratory had unsatisfactory scores for the 3rd event of 2024, and the 2nd Event of 2025. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 CASPER 0155D Report and graded results from the proficiency testing organization, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve an overall testing score of satisfactory performance for the endocrinology analyte: Free Thyroxine (FT4) . The laboratory had unsatisfactory scores for the 3rd event of 2024, and 2nd event of 2025. Findings include: 1. Review of the CASPER 0155D report revealed the following unsatisfactory scores: - 2024 Event 3 FT4: 0% - 2025 Event 2 FT4: 0% 2. Further review of the laboratory's 2024 and 2025 AAB-MLE PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the endocrinology analyte: FT4. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to ensure PT samples were tested the same number of times as patient specimens as required under subpart H for 1 of 2 AAB-MLE PT chemistry testing events in 2025. Findings include: 1. On the day of survey, 07/15/2025 at 9:06 am, review of the laboratory's AAB-MLE PT records revealed the laboratory failed to examine PT samples in the same manner as patient specimens for the following 1 of 2 AAB-MLE PT testing events in 2025: - AAB-MLE M2 2025 Thyroid Profile; CH 2. During interview with the TC, 07/15 /2025 at 11:00am, the TC stated "PT samples for Thyroid Stimulating Hormone (TSH) Free Thyroxine (FT4) and Free Triiodothyronine (FT3) were analyzed 3 times and the final result reported was based on the calculated average". 3. The laboratory could not provide documentation stating TSH, FT4 and FT3 were included in the laboratory's patient repeat criteria. 4. The TC confirmed the findings above on 07/15 /2025 at 1:00 pm. *REPEAT DEFICIENCY D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, lack of documentation and interview with the Technical Consultant (TC), the Laboratory Director (LD)/designee and testing personnel (TP) failed to attest that PT samples were tested in the same manner as patient specimens as required under subpart H for 6 of 6 AAB-MLE PT events performed in 2023, 2024 and 2025. Findings Include: 1. On the day of survey, 07/15/2025 at 9:06 am, the laboratory failed to provide attestation statements signed by the LD/designee and TP to document that PT samples were tested in the same manner as patient specimens for the following 6 of 6 AAB- MLE chemistry PT events performed in 2023, 2024 and 2025: - 2023 AAB-MLE Chemistry M3 Thyroid Profile - 2024 AAB-MLE Chemistry M1, M2 & M3 Thyroid Profile - 2025 AAB-MLE Chemistry M1 & M2 Thyroid Profile 2. The laboratory reported an estimated annual test volume of 7163 chemistry examinations performed in 2024 (CMS 116, dated 07/09/2025). 3. The TC confirmed the findings above on 07 /15/2025 at 1:00 pm. *REPEAT DEFICIENCY D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 for 2 of 2 years when moderate complexity chemistry testing was performed from 06/14/2023 to 07/15/2025. Findings include: 1. The laboratory failed to monitor and document room temperature and humidity to ensure proper reagent storage and operating conditions were met. Refer to D5413. 2. The laboratory failed to perform and document maintenance and function checks as defined by the manufacturer. Refer to D5429. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) (c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: -- 2 of 7 -- Based on record review, lack of documentation, and interview with the Practice Manager (PM), the laboratory failed to have a complete written procedure manual for endocrinology testing performed on 1 of 1 Abbott Architect i1000 SR immunoassay analyzer that met the requirements of 493.1251 (b)(1) through (b)(12) from 06/14 /2023 to the date of the survey. Findings include: 1. On the day of the survey, 07/15 /2025 at 11:00 am, review of the procedure manuals for endocrinology testing revealed the operator's manuals were used to perform testing on 1 of 1 Abbott Architect i1000 SR immunoassay analyzer from 06/14/2023 to 07/15/2025. 2. Review of the operator's manual revealed that the test system instructions used failed to include the following requirements of 493.1251 (b)(1) through (b)(12) that are specific to the laboratory: - Step by step performance of the procedure including test calculations and interpretation of results. - Preparation of slides, solution, calibrators, controls, reagents, stains, and other material used in testing. - Control procedures. - Calibration and calibration verification procedures. -

Summary Statement of Deficiencies D0000 A desk review for proficiency testing results was conducted by the Pennsylvania State Agency for Metabolic Disease Associates on 05/14/2025. The laboratory was found out of compliance with the following conditions: 493.803 Condition: Successful participation. 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 CASPER 0155 report and graded results from the proficiency testing (PT) organization, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate in PT for Thyroid Stimulating Hormone (TSH) and the sub-specialty of Endocrinology. The 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 -- laboratory had unsatisfactory scores for the 3rd event of 2024, and the 1st Event of 2025. Refer to D2107 and D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 CASPER 0155D Report and graded results from the proficiency testing organization, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve an overall testing score of satisfactory performance for the endocrinology analyte: Thyroid Stimulating Hormone (TSH) . The laboratory had unsatisfactory scores for the 3rd event of 2024, and 1st event of 2025. Findings include: 1. Review of the CASPER 0155D report revealed the following unsatisfactory scores: - 2024 Event 3 TSH: 0% - 2025 Event 1 TSH: 60% 2. Further review of the laboratory's 2024 and 2025 AAB-MLE PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the endocrinology analyte: TSH. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (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 review of the CASPER 0155D Report and graded results from the proficiency testing organization, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve an overall testing score of satisfactory performance for the sub-specialty: Endocrinology. The laboratory had unsatisfactory scores for the 3rd event of 2024, and 1st event of 2025. Findings include: 1. Review of the CASPER 0155D report revealed the following unsatisfactory scores: - 2024 Event 3 Endocrinology: 0% - 2025 Event 1 Endocrinology: 70% 2. Further review of the laboratory's 2024 and 2025 AAB-MLE PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the sub-specialty: Endocrinology. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: A. Based on review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with the administrative assistant, the laboratory failed to provide 3 of 6 PT attestation statements for clinical chemistry signed by the laboratory director or designee in 2022 and 2023. Findings Include: 1. On the day of the survey, 06/14/2023 at 12:05 PM, the following MLE PT attestation statements were not signed by the laboratory director or designee in 2022 and 2023: - Clinical Chemistry: (Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4), and Free Triiodothyronine (FT3)) - 2022 Event #3 - 2023 Event #1 - 2023 Event #2 2. The administrative assistant confirmed the findings above on 06/14/2023 around 4:00 PM. B. Based on review of the MLE PT records, the laboratory failed to prepare and examine 5 of 5 PT samples in the same manner as patient samples in 2022 and 2023. Findings Include: 1. On the day of the survey, 6/14/2023 at 12:05 PM, the laboratory records showed each PT sample analyzing TSH, FT4, and FT3 was ran 3 times and the result reported to MLE was the calculated average of the 3 runs. The PT events affected into 2022 and 2023 include: - Clinical Chemistry: (TSH, FT4, and FT3) - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 2022 Event #1 - 2022 Event #2 - 2022 Event #3 - 2023 Event #1 - 2023 Event #2 2. The administrative assistant confirmed the findings above on 06/14/2023 around 4:00 PM. C. Based on review of the MLE PT records, the laboratory failed to maintain copies of the proficiency testing program reports that record PT results for 4 of 6 PT events in 2022 and 2023. Findings include: 1. On the day of the survey, 6/14/2023 at 12:10 PM, the following MLE PT events were missing copies of the PT program reports that record PT results in 2022 and 2023: - Clinical Chemistry: (TSH, FT4, and FT3) - 2022 Event #1 - 2022 Event #2 - 2022 Event #3 - 2023 Event #1 - 2023 Event #2 2. The administrative assistant confirmed the findings above on 06/14/2023 around 4:00 PM. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 lack of documentation and interview with the administrative assistant, the laboratory failed to follow and establish a complete competency assessment procedure to assess 1 of 2 testing personnel (TP) performing endocrinology tests for their regulatory responsibilities from 7/14/2021 to the date of the survey. Findings include: 1. The Competency Policy states: "The assessment will be performed by the Laboratory Director or Director's designee" and "Staff who perform laboratory testing, will have a competency assessment at 6 months, 12 months and yearly thereafter." 2. On the day of survey, 06/14/2023, the laboratory could not provide competency assessment records for 1 of 2 TP (CMS 209 personnel #2) who performed endocrinology tests on the Architect from 7/14/2021 to the date of the survey. 3. The provided competency assessment for TP#2 did not have a completion date and was not signed off by the laboratory director or laboratory designee. 4. The administrative assistant confirmed the findings above on 06/14/2023 around 4:00 PM. **Repeat Deficiency** D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records and interview with the administrative assistant, the laboratory failed to define criteria for proper storage for the architect reagents and specimen housed in 2 of 2 freezers from 7/14/2021 to the day of survey. Findings Include: 1. On the day of survey, 6/14/2023 at 12:50 PM, review of the laboratory temperature records revealed, 2 of 2 freezers housing endocrinology -- 2 of 5 -- reagents and specimen did not have the correct criteria of storage from 07/14/2021 to the date of the survey 2. The administrative assistant confirmed the findings about on 06/14/2023 around 4:00 PM. ** Repeat Deficiency ** D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the administrative assistant, the laboratory failed to perform the recommended manufacturer maintenance on 1 of 1 Abbott Architect Plus from 07/14/2021 to the date of the survey. Findings include: 1. On the day of survey, 06/14/203 at 2:00 PM, the laboratory failed to provide documentation of recommended manufacturer maintenance for 1 of 1 Abbott Architect Plus from 07/14/2021 to the date of the survey. 2. The administrative assistant confirmed these findings on 6/14/2023 around 4:00 PM. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the administrative assistant, the laboratory failed to perform calibration verification at least once every six months as required for 1 of 1 Abbott Architect Plus for Thyroid Stimulating Hormone (TSH) in chemistry from 07/14/2021 to the date of the survey. Findings include: 1. On the date of the survey, 06/14/2023 at 12:30 PM, the laboratory could not provide calibration verification records for the required analytes including TSH. 2.The administrative assistant confirmed the findings above on 06/14/2023 around 4:00 PM. -- 3 of 5 -- D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Architect Plus quality control (QC) record review and interview with the administrative assistant, the laboratory failed to perform quality control for clinical chemistry analytes (Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4), and Free Triiodothyronine (FT3)) for 7 of 13 days in January 2022 and 13 of 17 days in February 2023 on 1 of 1 Abbott Architect Plus at least once each day of patient testing. Findings: 1. On the day of the survey, 6/14/2023 at 1:13 PM, the QC was not ran for TSH, FT4, or FT3 on following days of patient testing: - 01/05/2022, 01/06 /2022, 01/10/2022, 01/20/2022, 01/25/2022, 01/27/2022, 01/31/2022 - 02/02/2023, 02 /02/2023, 02/06/2023, 02/09/2023,02/13/2023, 02/14/2023, 02/16/2023, 02/20/2023, 02/21/2023, 02/22/2023, 02/23/2023, 02/27/2023, 02/28/2023 2. The administrative assistant confirmed the findings on 6/14/2023 around 4:00 PM D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the administrative assistant, the Laboratory Director (LD) failed to establish and follow written policies and procedures for an on-going mechanism to monitor, assess, and when indicated, correct problems identified in the laboratory from 7/21/2021 to the day of survey. Findings Include: 1. On the day of survey 06/14/2023 at 3:00 PM, the laboratory could not provide periodic evaluation of the laboratory that assess its pre-analytical, analytical, and post-analytical processes from 07/2021 to the date of the survey. 2. The administrative assistant confirmed the finding above on 06/14/2023 around 4:00 PM. ** Repeat Deficiency** D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all -- 4 of 5 -- personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on laboratory procedure review and interview with the administrative assistant, at the time of survey the laboratory director failed to ensure that a adequate procedure manual is available to the testing personnel (TP) responsible for performing clinical chemistry testing on 1 of 1 Abbott Architect Plus analyzer from 7/14/2021 to the date of the survey. Findings include: 1. On the day of the survey, 6/14/2023 at 12:45 PM, the laboratory provided a procedure manual from an outside faciliy's microbiology department for the Abbott Architect analyzer from 07/14/2021 to the date of the survey. 2. The provided procedure does not pertain to the chemistry testing performed in the laboratory. 3. The administrative assistant confirmed the findings on 6/14/2023 around 4:00 PM. -- 5 of 5 --

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 Medical Laboratory Evaluation (MLE) proficiency testing (PT) Records and Interview with the Practice Manager and Lab Supervisor, the laboratory failed to obtain signatures of testing personnel and the laboratory director on the PT attestation statements form 2020 and 2021. Findings Include: 1. On the day of survey, 07/14/2021, review of the MLE PT records revealed, the individuals testing the PT samples and the laboratory director did not sign the attestation statements for the following event in 2020 and 2021. 2020 MLE - Event #1. 2021 MLE - Events #1 and #2. 2. The Practice Manager and Lab Supervisor confirmed the findings above on 07/14/2021 around 10:15 am. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 review of laboratory procedure manuals and interview with the Practice Manager and Lab Supervisor, the laboratory failed to follow and establish a complete competency assessment procedure to assess 5 of 5 testing personnel (TP) performing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- endocrinology tests, fine needle aspirate (FNA) examinations and 2 of 3 technical consultant (TC) for their regulatory responsibilities in 2019 to the day of survey. Findings include: 1. The Competency Policy states, "Staff who perform laboratory testing, will have a competency assessment at 6 months, 12 months and yearly thereafter." 2. On the day of survey, 07/14/2021, the laboratory could not provide competency assessment records for 4 of 4 testing personnel including the 6 points of competency assessment who performed endocrinology tests on the Architect in 2019, 2020 and 2021. 3. The laboratory could not provide competency assessment records for 1 of 1 TP performing FNA examinations in 2020 and 2021. 4. The laboratory could not provide a complete policy to assess the competency of 2 of 3 TC (#2 and #3) for their regulatory responsibilities in 2019, 2020 and 2021. 5. The Practice Manager and Lab Supervisor confirmed the findings above on 07/14/2021 around 9: 30 am. 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: Based on review of the laboratory procedure manual and interview with the Practice Manager and Lab Supervisor, the laboratory failed to establish a Fine Needle Aspiration (FNA) and Architect Chemistry analyzer procedure for 2019 to the day of survey. Findings include: 1. On the day of survey, 07/14/2021, the laboratory could not provide a FNA or Architect Chemistry analyzer procedure in place from 07/14 /2019 to 07/14/2021. 2. The Practice Manager and Lab Supervisor confirmed the finding above on 07/14/2021 around 10:00 a.m. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with the Practice Manager and Lab Supervisor, the Laboratory Director failed to approve the laboratory procedures in use from 07/14/2019 to the day of survey. Findings include: 1. On the day of survey, 07/14/2021, review of the laboratory procedures revealed, the current Laboratory Director failed to sign and date laboratory procedures prior to use from 07 /14/2019 to 07/14/2021. 2. Practice Manager and Lab Supervisor confirmed the above findings on 07/14/2021 around 10: 50 pm. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and -- 2 of 5 -- test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records and interview with the Practice Manager and Lab Supervisor, the laboratory failed to define criteria for proper storage for the architect reagents and specimen housed in 2 of 2 freezers from 2019 to the day of survey. Findings Include: 1. On the day of survey, review of the laboratory temperature records revealed, 2 of 2 freezers housing endocrinology reagents and specimen did not have defined criteria of storage from 2019 to June 2021. 2. The Practice Manager and Lab Supervisor confirmed the findings about on 07/14/2021 around 11:05 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, lack of documentation and interview with the Practice Manager and Lab Supervisor, the laboratory failed to perform maintenance of laboratory equipment from 2019 to the day of survey. Findings include: 1. On the day of survey, 07/14/2021, observation of the laboratory revealed the following laboratory equipment was due for maintenance: Freezer A thermometer, service sticker stated, " Calibration Due 08/20/2015". 1 of 1 Quest Diagnostic Horizon mini E centrifuge, service sticker stated, " Calibration Due 04/17". 2. The laboratory could not provide a maintenance procedure policy . 3. The Practice Manager and Lab Supervisor confirmed the findings about on 07/14/2021 around 11:06 am. D5781