Highland Clinic Laboratory

Summary Statement of Deficiencies D0000 A Certification survey was performed on October 18, 2023 at Highland Clinic Laboratory, CLIA ID 19D0463720. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 laboratory policy, proficiency testing records and interview with personnel, the laboratory failed to ensure the Laboratory Director and/or designee signed the attestation statement for one (1) of sixteen (16) proficiency testing (PT) events reviewed in 2022 and 2023. Findings: 1. Review of the laboratory's policy for "External Proficiency Testing Guideline" revealed "The analyst and laboratory director or designee must sign the attestation statement provided by the PT agency documenting that the proficiency testing samples were tested in the same manner as patient samples". 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records from 2022 and 2023 revealed the Laboratory Director or designee did not sign the attestation statement for the following one (1) of sixteen (16) PT events reviewed: a) 2023 Chemistry Core 3rd event 3. In interview on October 18, 2023 at 12:25 pm, the General Supervisor confirmed the Laboratory Director or designee did not sign the attestation statements as required for the identified event. D5429 MAINTENANCE AND FUNCTION CHECKS 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 -- 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 by surveyor, review of maintenance records and interview with personnel, the laboratory failed to ensure the monthly maintenance on the Roche Cobas C 501 chemistry analyzer was performed as required by the manufacturer. Findings: 1. Observation by surveyor during the laboratory tour on October 19, 2023 at 10:00 am revealed the laboratory utilizes the Roche Cobas analyzer for chemistry tests. 2. Review of the laboratory's Roche Cobas C 501 module maintenance records revealed the laboratory performs the following monthly maintenance: a) Clean: Incubation water bath KCL aspiration filter Detergent aspiration filters Circuit board rack filter Power supply filter Radiator filter b) Replace: Reaction cells 3. Further review of the Roche Cobas c 501 module maintenance records from 2022 and 2023 revealed the laboratory did not perform the following monthly maintenance for one (1) of twenty one (21) months reviewed: a) September 2022 4. In interview on October 18, 2023 at 12:30 pm, the General Supervisor confirmed the laboratory did not perform the identified maintenance. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Recertification survey was performed on December 29, 2021 through December 30, 2021 at Highland Clinic Laboratory, CLIA ID # 19D0463720. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written, detailed instructions that included the following: a) Normal Mean Prothrombin Time Study questionnaire to include the CLSI 28-A3 recommendation for donor requirements: No medication including oral contraceptives and estrogen 2. In interview on December 29, 2021 at 2:44 pm, Personnel 2 stated she was unaware the above information needed to be included in the laboratory policy. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 direct observation by surveyor, review of laboratory policy and procedure and interview with personnel, the laboratory failed to ensure supplies did not exceed their expiration date. Findings: 1. Direct observation by surveyor during the laboratory tour on December 29, 2021 at 10:10 am revealed the following expired supplies located in a drawer in phlebotomy room #5: a) BD vacutainer Sodium Heparin 10.0 mL tubes, Lot 9220473, Expiration 8/31/21, Quantity: two (2) b) BD vacutainer Lithium Heparin 6.0 mL tube, Lot 0072519, Expiration 8/31/21, Quantity: one (1) c) BD vacutainer Lithium Heparin 6.0 mL tube, Lot 0133380, Expiration 10/31 /21, Quantity: one (1) 2. Review of the laboratory's policy "Reagent Labeling and Expiration" revealed "Reagents, solutions, culture media, controls, calibration materials and other supplies are not to be used when they have exceeded expiration dates, have deteriorated or are of sub-standard quality". 3. In interview on December 29, 2021 at 11:19 am, Personnel 2 confirmed the above identified supplies located in phlebotomy room 5 were expired. 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 by surveyor, review of the laboratory's maintenance logs and interview with personnel, the laboratory failed to ensure monthly maintenance for the Roche Hitachi Cobas 6000 Chemistry analyzer was performed per manufacturer instructions for two (2) of twenty four (24) months reviewed. Findings: 1. Observation by surveyor during the laboratory tour on December 29, 2021 at 10:41 am revealed the laboratory utilizes the Roche Hitachi Cobas 6000 analyzer for the following chemistry testing: Creatinine (CREA), Glucose (GLUC), Albumin (ALB), Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), Amylase (AMY), Aspartate Aminotransferase (AST), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Blood Urea Nitrogen (BUN), Calcium (CA), Carbon Dioxide (CO2), Cholesterol (CHOL), Gamma-Glutamyl Transferase (GGT), High Density Lipoprotein (HDL), Iron (FE), Lactate Dehydrogenase (LDH), Low Density Lipoprotein (LDL), Lipase (LIP), Magnesium (MG), Phosphorous (PHOS), Total Protein (TP), Triglycerides (TRIG), Unsaturated Iron Binding Capacity (UIBC), Uric Acid (UA), Sodium (NA), Potassium (K), Chloride (CL), C-Reactive Protein (CRP), Rheumatoid Factor (RF), Urine Creatinine (UCREA), Urine Protein (UPROT), Hemoglobin A1C (HGB A1C), Beta-Human Chorionic Gonadotropin (BHCG), Progesterone (PROG), Ferritin (FER), Folate (FOLA), Free Triiodothyronine (FT3), Free Thyroxine (FT4), Prolactin (PROL), Prostate-Specific Antigen (PSA), Testosterone (TEST), Total Triiodothyronine (TT3), Total Thyroxine (TT4), Thyroid Stimulating Hormone (TSH), Vitamin B12 (B12), Carcinoembryonic Antigen (CEA) 2. Review of the laboratory's "Cobas 6000 analyzer series Sampling Unit" maintenance log revealed the following monthly maintenance tasks: a) Clean Sampling unit filter b) Inspect /Clean DI water tank 3. Further review of the laboratory's "Cobas 6000 analyzer series Sampling Unit" maintenance log from January 2020 through December 2021 revealed the laboratory did not have documentation of performing the monthly maintenance for -- 2 of 4 -- the following two (2) of twenty four (24) months reviewed: a) April 2020: Clean Sampling unit filter, Inspect/Clean DI water tank b) September 2021: Clean Sampling unit filter 4. In interview on December 30, 2021 at 10:47 am, Personnel 2 confirmed the above monthly maintenance was not documented as performed for identified months. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation during laboratory tour, review of laboratory records and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to ensure supplies did not exceed their expiration date. Refer to D5417. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on observation by surveyor during laboratory tour, review of laboratory records, and interview with personnel, the Laboratory Director failed to ensure that the laboratory performed the required maintenance to ensure acceptable levels of analytical performance. Findings: 1. The laboratory failed to ensure monthly maintenance for the Roche Hitachi Cobas 6000 Chemistry analyzer was performed per manufacturer instructions for two (2) of twenty four (24) months reviewed. Refer to D5429. 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 personnel responsible for any aspect of the testing process; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedure manual and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation during the laboratory tour, review of laboratory records and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to ensure supplies did not exceed their expiration date. Refer to D5417. 2. The laboratory failed to ensure monthly maintenance for the Roche Hitachi Cobas 6000 Chemistry analyzer was performed per manufacturer instructions for two (2) of twenty four (24) months reviewed. Refer to D5429. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Highland Clinic Laboratory - CLIA ID # 19D0463720 on September 10, 2019 through September 11, 2019. Highland Clinic Laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.807 CONDITION: Reinstatement of laboratories performing nonwaived testing 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This CONDITION is not met as evidenced by: Based on review of proficiency testing results from the CMS-155D and American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing as evidence by: 1. The laboratory failed to achieve a satisfactory score for Human Chorionic Gonadatropin (HCG) for three (3) of four (4) proficiency testing events resulting in non-initial unsuccessful performance. Refer to D2107. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of proficiency testing results, the laboratory failed to achieve a satisfactory score for Human Chorionic Gonadatropin (HCG) for three (3) of four (4) proficiency testing events resulting in non-initial unsuccessful participation. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 record review, the laboratory failed to achieve a satisfactory score for Human Chorionic Gonadatropin (HCG) for three (3) of four (4) proficiency testing events resulting in non-initial unsuccessful performance. Findings: 1. Review of the API Proficiency Testing Records revealed the laboratory did not achieve a score of at least 80% for the specialty of Endocrinology for the following events: a) For the 1st event in 2018 the laboratory received a score of 40% for Human Chorionic Gonadotropin (HCG) *unacceptable for HCG-02, HCG-03, and HCG-04 b) For the 2nd event in 2018 the laboratory received a score of 40% for Human Chorionic Gonadotropin (HCG) *unacceptable for HCG-07, HCG-09, and HCG-10 c) For the 1st event in 2019 the laboratory received a score of 60% for Human Chorionic Gonadotropin (HCG) *unacceptable for HCG-04 and HCG-05 2. In interview on September 10, 2019 at 12:40 am, Personnel 4 stated the laboratory chose the wrong -- 2 of 12 -- peer group for the 1st and 2nd events in 2018 and reversed the results for 1st event in 2019. Personnel 4 further stated that all the above failures were clerical errors by the previous technical consultant. D2121 HEMATOLOGY CFR(s): 493.851(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 CMS 155D Report, American Proficiency Institute (API) and interview with personnel, the laboratory failed to attain a score of at least 80% for the Blood Cell Identification testing. Findings: 1. Review of the API Proficiency Testing Records revealed the laboratory did not achieve a score of at least 80% for the specialty of Hematology for the following events: a) For the 2rd event in 2018 the laboratory received a score of 40% for Blood Cell Identification. *unacceptable for BCI-15, BCI-17, and BCI-18 2. In interview on September 10, 2019 at 12:40 am, Personnel 4 stated the previous Technical Consultant performed the Blood Cell Identification for this API survey. Personnel 4 further stated she was unaware if the

Summary Statement of Deficiencies D0000 A PT Desk Review SURVEY was performed on September 25, 2018. Highland Clinic Laboratory- 19D0463720 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 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 record review of CMS Casper Reports 0153D and 0155D, the laboratory failed to successfully participate in Proficiency Testing as follows: 1. The 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 -- failed to obtain a satisfactory score for two of three Proficiency Testing events in Endocrinology. Refer to D2107 D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a review of proficiency testing results, the laboratory failed to achieve satisfactory performance for Human Chorionic Gonadotropin (HCG) in 2 of 3 consecutive events resulting in an initial unsuccessful performance. The findings are as follows: 1. Review of proficiency testing evaluation reports from CASPER Reports 0153D and 0155D revealed unsatisfactory performance resulting in an initial unsuccessful performanc as follows: a. First Event 2018 with a score of 40% b. Second Event 2018 with a score of 40% 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. This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. 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: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to achieve satisfactory performance for Endocrinology in two of three consecutive events resulting in initial unsuccessful performance. Refer to D2107. -- 2 of 2 --