Jackson Clinic, Pa North Convenient Care, The

Summary Statement of Deficiencies D0000 During a recertification survey performed on May 13, 2026, the laboratory was found out of compliance with the following condition: D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) (a)(3)(i) Records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on a review of new method validation records, and staff interview, the laboratory failed to retain the validation raw data for the high sensitivity cardiac Troponin I (hs-TnI) assay performed on the Polymedco Pathfast instrument (one of two new test systems reviewed). The findings include: 1. A review of new test validation records revealed that the hs-TNI performed on the Polymedco Pathfast instrument was put into use for patient testing on 11/10/25. The raw data that supported the validation summary dated 11/4/25, was not available on the survey date (comparisons, accuracy, precision, linearity). 2. Technical consultant one confirmed the survey findings during an interview on 05/13/26 at 4:45 p.m. 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. 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 -- This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), a review of testing personnel records, a review of the laboratory procedure manual, and staff interview, the laboratory failed to follow the policy for performing annual competency assessment for two of two testing personnel when it did not perform 2024 annual competency assessments for any test system, and failed to include manual differential in the 2025 annual competency assessments. The findings include: 1. Laboratory observation on 05/13/26 at approximately 8:10 a.m. revealed the following moderately complex test systems used for performing patient testing: the Sysmex XN- 21 N for performing Complete Blood Count with automated White Blood Cell differential (CBC w/Diff), a microscope used for performing urine sediment examination, wet prep examination, Potassium Hydroxide (KOH) hair, skin, and nail examination, fecal white blood cell examination, and manual differential, a Polymedco PathFast used for performing fibrin degradation products (D-Dimer), N- terminal pro B-type natriuretic peptide (NT-proBNP) and high sensitivity cardiac Troponin I (hs-TnI), and an Alcor MiniiSED used for performing erythrocyte sedimentation rate (ESR). 2. A review of the FORM CMS-209 revealed two testing personnel. The same two TP were listed on the FORM CMS-209 from the previous survey completed on 09/17/24. 3. A review of testing personnel records (TP One and TP Two) revealed no documented annual competency assessments in 2024 for any test system, manual differential competency assessment was not performed in 2025. 4. A review of the laboratory personnel policy revealed that competency assessments were required initially, at 6 months, and annually thereafter. 5. Technical consultant two (as listed on the FORM CMS-209) confirmed the survey findings during an interview on 05/13/26 at approximately 10:35 a.m. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and a staff interview, on the survey date, the laboratory was not enrolled in a PT module for the examination of fungal elements in hair, skin, and nail specimens. The findings include: 1. Laboratory observation on 05/13/26 at approximately 8:10 a.m. revealed a microscope used for examination of hair, skin, and nails for fungal elements using Potassium Hydroxide (KOH) reagent. 2. A review of the laboratory's API PT 2026 enrollment revealed that the laboratory was not enrolled in a KOH PT module that included hair, skin, and nail specimens. 3. During an interview on 05/13/26 at approximately 12:30 p.m., technical consultant one stated that the laboratory used PT samples to verify the accuracy of fungal element detection in hair, skin, and nail specimens, and confirmed the laboratory was not enrolled in a module that included those specimen types. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each -- 2 of 7 -- of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory procedure manual, and staff interview, the laboratory failed to have procedures for venipuncture blood collection, capillary blood collection, and specimen labeling on the date of the survey (05/13/26). The findings include: 1. Laboratory observation on 05/13/26 at approximately 8:10 a.m. revealed the following moderately complex test systems used for performing patient testing: the Sysmex XN-21 N for performing CBC w/Diff, a microscope used for performing urine sediment examination, wet prep examination, KOH hair, skin and nail examination for fungal elements, fecal white blood cell examination, and manual differential, a Polymedco PathFast used for performing fibrin degradation products (D-Dimer), N-terminal pro B-type natriuretic peptide (NT- proBNP) and high sensitivity cardiac Troponin I (hs-TnI), and an Alcor MiniiSED used for performing erythrocyte sedimentation rate (ESR). Supplies and tubes for performing venipuncture and capillary blood collection were noted during the observation. 2. A review of the laboratory procedure manual revealed no procedures for venipuncture and capillary blood collection, or specimen labeling requirements. 3. Technical consultant one (as listed on FORM CMS-209) confirmed the survey findings during an interview on 05/13/26 at 1:50 p.m. 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, a review of the laboratory's 2025 and 2026 calibration verification documents, a review of a patient test report, a review of a patient activity report, and staff interview, the laboratory failed to follow the procedure for six-month calibration verification for the D-Dimer analyte (one of three analytes) performed on the Polymedco Pathfast instrument, with approximately 54 patient D-Dimer results reported during the gap in calibration verification from 03/04/25 until 09/06/25. The findings include: 1. Laboratory observation on 05/13/26 at approximately 8:10 a.m. revealed the Polymedco PathFast used for performing D-Dimer, NT-proBNP, and hs-TnI. 2. A review of the laboratory procedure titled "Polymedco Pathfast Cardiac Biomarker Immunoassay" revealed that calibration verification would be performed every six months for the three analytes performed on the Polymedco PathFast instrument. 3. A review of the laboratory's calibration verification documents revealed that the calibration verification for D-Dimer that was due on 03/04/25 was not performed until 09/06/25 (one of three calibration verifications for the D-Dimer analyte). 4. A review of a patient test report revealed patient sample number 925226264 reported on 08/14 /25 during the gap in calibration verification for the D-Dimer analyte. 5. A review of a -- 3 of 7 -- patient activity report revealed that approximately 54 patient D-Dimer results were reported during the gap in calibration verification for the D-Dimer analyte. 6. Technical consultant one confirmed the survey findings during interview on 05/13/26 at approximately 4:45 p.m. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 a review of test validation records, a review of the procedure manual, and staff interview, the laboratory director failed to approve the new Alcor MiniiSED ESR procedure prior to patient testing that began on 03/13/2026. The findings include: 1. A review of test validation records revealed that the Alcor MiniiSED ESR instrument was put into use on 03/13/26. 2. A review of the Alcor MiniiSED procedure revealed that the procedure had not been approved by the laboratory director. 3. Technical consultant one confirmed the survey findings during an interview on 05/13/26 at approximately 4:45 p.m. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the control manufacturer's instructions for use, and staff interview, the laboratory failed to ensure that one of three hematology controls was not used past the expiration date on the date of the survey. The findings include: 1. Laboratory observation on 05/13/26 at approximately 8:10 a. m. revealed a Sysmex KX-21N instrument that was used for performing patient testing for CBC w/Diff. Three levels of EightCheck 3WP CBC controls were observed, labeled with open date and corrected expiration dates. One of the three (lot 60760712) was labeled as opened on 04/26/26, with a corrected expiration date of 05 /17/26 (21 days). 2. A review of the manufacturer's instructions for use revealed that the controls were stable for 14 days after opening. Based on the manufacturer's instructions, the labeled control open expiration date should have been 05/10/26, resulting in the use of the control three days past the open expiration date. 3. Technical consultant one confirmed the survey findings during an interview on 05/13 /26 at approximately 4:45 p.m. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test -- 4 of 7 -- performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of a final patient test report for Potassium Hydroxide (KOH), and staff interview, the final patient test report failed to include the units of measure for KOH (one of twenty) analytes reviewed. 1. A review of a final patient test report for KOH revealed no units of measure (patient medical record number 2976207, reported on 03/05/26). 2. Technical consultant one confirmed the survey findings during interview on 05/13/26 at approximately 4:45 p.m. 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 a review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209) and the Aspen Web 116 database, a review of the laboratory director job description, lack of documentation, and staff interview, on the survey date, the laboratory director listed on the FORM CMS-209 failed to qualify as director due to a lack of documentation of either one year directing moderately complex testing, or the required 20 Continuing Medical Education (CME) credits. Refer to D6003. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; and (b)(2)(ii)(B) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in 493. 1407; or (b)(3)(i)(A) Hold an earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or (b)(3)(i)(B) Hold an earned doctoral degree; and (b)(3)(i)(B)(1) Have at least 16 -- 5 of 7 -- semester hours of doctoral level coursework in biology, chemistry, medical technology (MT), clinical laboratory science (CLS), or medical laboratory science (MLS); or (b)(3)(i)(B)(2) An approved thesis or research project in biology/chemistry /MT/CLS/MLS related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (b)(3)(ii) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in 493.1407; and (b)(3)(ii)(A) Be certified and continue to be certified by a board approved by HHS; and (b)(3)(ii)(B) Have had at least 1 year of experience directing or supervising nonwaived laboratory testing; or (b)(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B)(1) Meet bachelor's degree equivalency; and (b)(4)(i)(B)(2) Have at least 16 semester hours of additional graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science; or (b)(4)(i)(C)(1) Meet bachelor's degree equivalency; and (b)(4)(i)(C)(2) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science coursework and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (b)(4) (ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing; and (b)(4)(iii) Have at least 1 year of supervisory laboratory experience in nonwaived testing; and (b)(4)(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in 493.1407; or (b)(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(5)(i) (B) At least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either- (b)(5)(i)(B)(1) 48 semester hours of medical laboratory science or medical laboratory technology courses; or (b)(5)(i)(B)(2) 48 semester hours of science courses that include- (b)(5)(i)(B)(2)(i) 12 semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry; and (b) (5)(i)(B)(2)(ii) 12 semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and (b)(5)(i)(B)(2)(iii) 24 semester hours of chemistry, biology, or medical laboratory science or medical laboratory technology in any combination; and (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing; and (b)(5)(iii) Have at least 2 years of supervisory laboratory experience in nonwaived testing; and (b)(5)(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in 493.1407. (b)(6) Notwithstanding any other provision of this section, an individual is considered qualified as a laboratory director of moderate complexity testing under this section if they were qualified and serving as a laboratory director of moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on a review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209) and the Aspen Web 116 database, a review of the laboratory director job description, lack of documentation, and staff interview, on the survey date, the laboratory director listed on the FORM CMS-209 failed to qualify as director due to a lack of documentation of either one year directing moderately complex testing, or the required 20 CME credits. The findings include: 1. A review of the Form CMS-116 and FORM CMS-209 survey -- 6 of 7 -- forms, and the Aspen Web 116 database, revealed the name of a laboratory director that did not match the name of the laboratory director listed in the ASPEN Web 116 database. 2. A review of job descriptions revealed that the laboratory director listed on the CMS survey forms signed a laboratory director job description on 05/04/26. 3. A review of the laboratory director's qualifications revealed no documentation that qualified the director to direct moderately complex patient testing. 4. Technical Consultant One (as listed on the FORM CMS-209) confirmed the survey findings during an interview on 05/13/26 at approximately 4:45 p.m. -- 7 of 7 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observations of the laboratory, review of quality control (QC) records, and staff interview, the laboratory failed to retain the "MC ENTRY CARD" that comes in each box of reagent for the PATHFAST instrument resulting in the laboratory not being able to tie the box lot number (as printed on the control data sheet), and corresponding QC ranges, to the lot number on the QC printouts. The findings include: 1. Observation of the laboratory on 08/16/23 at 8:40 am revealed the Polymedco PATHFAST instrument in use for patient testing for Troponin I, B-Type Natriuretic Peptide (NT-ProBNP), and Fibrin Degradation Product (D-Dimer). 2. Observation of a box of test cartridge reagents on 08/16/23 at 1:30 pm revealed the following: Each box of reagent comes with a "MC ENTRY CARD" that has a unique lot number and expiration date which is scanned when setting up new lot numbers of reagent in the instrument. The box also comes with a control data sheet that includes lot specific QC ranges and references the Lot # that is on the outside of the box, which is different from the lot number on the MC ENTRY CARD. The lot number from the MC ENTRY CARD was not included on the manufacturer's control data sheet. 3. Review of quality control records for the Troponin I and NT-ProBNP performed on 05 /05/23 revealed the following: The reagent lot number from the MC ENTRY card was printed on each of the QC printouts. The box lot number that is included on the control data sheet was not captured on the QC printouts. Troponin I QC revealed the use of reagent lot # 1102405654 on the QC printouts. The corresponding MC ENTRY CARD was not retained with the Control Range Data Sheet. NT-proBNP QC revealed the use of reagent lot # 1062407628. The MC ENTRY CARD was not retained with 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 -- the Control Range Data Sheet. 4. Interview with technical consultant number one on 08/16/23 at 3:30 pm confirmed the laboratory failed to retain the MC ENTRY CARD that comes in each box of PATHFAST reagents, resulting in the laboratory not being able to tie the box lot number (and appropriate QC ranges) to the lot number (as scanned from the MC ENTRY CARD) on the QC instrument printouts. He confirmed there was no process in place to tie the reagent lot number on the MC ENTRY CARD to the box lot number and corresponding QC values on the control data sheet. 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 the laboratory's testing personnel policy, testing personnel (TP) competency assessment records, patient test reports and staff interview, the laboratory policy for competency assessment was not followed when two of two established TP did not have annual competency assessments in 2022, and the competency forms in use did not include all six elements for each test performed by the TP in 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's testing personnel policy revealed that TP competency assessments would be performed annually during the first year and then annually thereafter. It also indicated that the six required procedures would be included for each test the individual is approved to perform. 2. Review of personnel records revealed the following: a. No competency assessments were performed for testing personnel numbers one and two in 2022 (two of two established TP). b. The competency assessment forms in use did not include the following: Direct observation and record review was not included for manual differential. Direct observation and record review was not included for Potassium Hydroxide (KOH). Monitoring of test result recording and reporting did not specify which test(s). Blind testing did not specify which test(s). Assessment of problem solving skills did not specify which test(s). c. Competency assessments were performed using these forms in 2021, 2022, and 2023. d. The problem solving tests used for the 2023 competency for testing person number one were not graded. 3. Review of patient test reports revealed patient testing for manual differential performed 08/16/21 (patient 6152902), 09/16/22 (patient 99677318), and 08/15/23 (patient 99772098); KOH performed 09/04/21 (patient 3421112), 04/04/22 (patient 22045469), and 03/21/23 (patient 100163460). 4. Interview with technical consultant number one on 08/16/23 at 3:30 pm confirmed the laboratory did not follow its' own policy for competency assessment when competency assessments were not performed for TP numbers one and two in 2022, it failed to include all six elements for each test performed in 2021, 2022, and 2023, and the problem solving tests for TP number one for 2023 was not graded. He also confirmed the competency did not include direct observation and record review for manual differential and KOH in 2021, 2022, and 2023 with patient testing performed. 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 3 -- 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 observation of the laboratory, review of manufacturers' operator's manual, lack of records, and staff interview, the laboratory failed to monitor humidity in the area where the Sysmex KX-21N Complete Blood Count with automated white blood cell differential (CBC w/Diff) instrument and the PASTFAST chemistry instrument were in use. The findings include: 1. Observation of the laboratory on 08/16/23 at 8: 40 am revealed the Sysmex KX-21N (serial #F2734) in use for performing patient testing for CBC w/Diff and the PathFast instrument (serial # 1906D3548) in use for performing patient testing for Troponin I, B-type Natriuretic Peptide (BNP), and Fibrin Degradation Product (D-Dimer). No device for monitoring of humidity was observed in the laboratory. 2. Review of the manufacturers' operator's manuals revealed the following humidity requirements: Sysmex KX-21N CBC instrument = 30 - 85% PATHFAST Instrument = 20 - 80% Relative Humidity 3. There were no records for humidity monitoring. 4. Interview with technical consultant number two on 08/16/23 at 3:30 pm confirmed the laboratory did not monitor the humidity in the area where the Sysmex KX-21N CBC instrument and the PATHFAST chemistry instrument were in use. -- 3 of 3 --

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: The laboratory failed to maintain satisfactory participation in two consecutive proficiency testing (PT) events for the cell identification analyte, resulting in the first unsuccessful PT occurrence for the cell identification analyte. (Refer to D2130) D2130 HEMATOLOGY 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. 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 desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2020 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Cell Identification analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory Cell Identification scores: 2020 Event two = 60% 2020 Event three = 0% 2. Review of the laboratory's 2020 PT event two hematology evaluation report revealed sample numbers BCP-13 and BCP-15 scored as unacceptable resulting in a score of 60% for the cell identification analyte. 3. Review of the 2020 PT event three hematology evaluation report revealed a score of 0% for cell identification due to "Results for this kit were not received," resulting in the first unsuccessful PT occurrence for the Cell Identification analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the validation studies performed for the Alere Triage meter (serial # 00046321) and interview with the technical consultant, the laboratory failed to perform studies for verification of manufacturer's performance specifications for precision and reportable range for the Alere Triage Meter in 2018. The findings include: 1. Review of the validation studies performed in March 2018 for the Alere Triage meter (serial number 00046321) revealed no studies were available for verification of manufacturer's performance specifications for precision and reportable range. 2. Interview with the technical consultant on June 13, 2018 at 1pm confirmed that the validation studies performed for the Alere Triage meter (serial # 00046321) did not include studies for precision and reportable range. The laboratory reports D- dimer, CKMB, myoglobin, and troponin on this instrument and began reporting patients on April 1, 2018 with approximately 50 patients reported since installation of the meter. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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 observation of the laboratory, review of the laboratory's procedure for the Alere Triage meter, the laboratory's procedure manual, the Food and Drug Administration (FDA) database for test complexity, interview with the instrument manufacturer technical services, patient test reports and the laboratory's quality control records for the Triage meter, and interview with the technical consultant the laboratory failed to perform two levels of control each day of patient testing for the CKMB, myoglobin and troponin analytes in 2016, 2017, and 2018. The findings include: 1. Observation of the laboratory on June 13, 2018 at 9:00 am revealed the Alere Triage meter in use for patient testing. 2. Review of the laboratory's procedure for the Alere Triage meter revealed the following: The meter is used for performing CKMB, myoglobin, and troponin. The control frequency is every 30 days and when a new lot number of a kit is opened. 3. Review of the laboratory's procedure manual revealed there was no individualized quality control plan (IQCP) in place for the reduced frequency of quality control for the Alere Triage meter for the CKMB, myoglobin, and troponin analytes. 4. Review of the FDA database for test complexity revealed that the CKMB, myoglobin and troponin analytes performed on the Alere Triage meter are moderately complex tests. 5. Interview via phone on June 15, 2018 at 2:30 pm with the manufacturer's technical services confirmed that the tests for CK- MB, myoglobin and troponin-I performed on the Triage meter are moderately complex. 6. Review of patient number thirteen test report and quality control for the months of June and July 2016 revealed CK-MB, myoglobin and troponin patient testing reported on 07.26.2016 with quality control last performed on 06.23.2016. 7. Review of patient number ten test report and quality control for the months of April and May 2017 revealed patient testing performed on 5.2.17 with quality control last performed on 04.13.17. 8. Interview with the technical consultant on June 13, 2018 at 4:00 pm confirmed the laboratory reports patient testing for CK-MB, myoglobin and troponin using the Alere Triage meter, follows the laboratory's procedure for quality control frequency, does not perform two levels of quality control each day of patient testing, and does not have an IQCP in place for reduced frequency of quality control in 2016, 2017, and 2018. -- 2 of 2 --