Jackson Clinic, Pa - Innovation Park, The

Summary Statement of Deficiencies D0000 During a recertification survey performed on November 4, 2025, the laboratory was found out of compliance with the following condition: 493.1210 Condition: Routine chemistry. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on laboratory observation, procedure manual review, a review of quality control records, patient activity reports, lack of documentation and staff interview, the laboratory failed to follow the established procedure for quality control (QC)

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) attestation statements and staff interview, testing personnel failed to sign four of thirty proficiency testing attestation statements from 2023 and 2024. The findings include: 1. A review of the laboratory's CAP PT records revealed the following attestation statements that had not been signed by testing personnel: 2023 CGL-C (Coagulation-event three), 2023 CM-B (Clinical Microscopy-event two), 2024 CM-A (Clinical Microscopy-event one), 2024 U-A (Urine Chemistry- event one). 2. During an interview on 06/20/24 at 11:30 a.m., the laboratory director confirmed testing personnel failed to sign four of thirty attestation statements from 2023 and 2024. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: CITATION ONE: Based on observation of the laboratory, review of 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 3 -- procedure manual, lack of documentation, and staff interview, the laboratory failed to follow the procedure for performing revolutions per minute (RPMs) and timer checks on the Stat Spin centrifuge used for processing patient specimens for Prothrombin Time (PT) and activated Partial Thromboplastin Time (aPTT) in 2023 and 2024. The findings include: 1. Observation of the laboratory on 06/18/24 at 8 a.m. revealed the Sysmex CA 620 instrument (serial number 23742) used for performing patient testing for PT and aPTT. Next to the instrument was a Stat Spin centrifuge (serial number 1603M50110085) used to process specimens for PT and aPTT testing. 2. A review of the laboratory's procedure manual revealed that the laboratory would check the RPMs and timers of centrifuges biannually. 3. There was no documentation of RPM or timer checks for the Stat Spin centrifuge. 4. The laboratory director confirmed during interview on 06/20/24 at 11:30 a.m. that the laboratory did not follow its own policy for performing RPM and timer checks on the Stat Spin centrifuge in 2023 or 2024. CITATION TWO: Based on observation of the laboratory, review of the laboratory procedure manual, lack of records, review of a patient test report and staff interview, the laboratory failed to ensure the procedure for use of platelet-poor plasma for testing PT and aPTT analytes was followed when it did not validate the Stat Spin centrifuge to ensure platelet-poor plasma was produced during sample processing. The findings include: 1. Observation of the laboratory on 06/18/24 at 8 a.m. revealed the Sysmex CA 620 instrument (serial number 23742) used for performing patient testing for PT and aPTT. Next to the instrument was a Stat Spin centrifuge (serial number 1603M50110085) used to process specimens for PT and aPTT testing. 2. A review of the laboratory procedure for PT and aPTT revealed the following statement under the section for "Handling Conditions:" "Centrifuge the capped specimen tube for a minimum of 15 minutes at 1500 g to consistently produce platelet-poor plasma" The criteria listed as the definition for platelet poor plasma was a platelet count of less than 10 x 10^9 per Liter. 3. There was no documentation that the centrifuge had been tested to ensure the production of platelet-poor plasma. 4. Review of a patient test report revealed patient testing for PT and aPTT on patient sample number 23147634 on 11/20/23. 5. During an interview on 06/20/24 at 11:30 a.m., the laboratory director confirmed that the laboratory failed to test the Stat Spin centrifuge to ensure it could produce the platelet-poor plasma required for PT and aPTT testing. 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 observation of the laboratory, review of patient test reports, review of laboratory procedure, and staff interview, the laboratory failed to ensure the procedure for the Sysmex XN 530 Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff) was approved by the laboratory director before patient testing that began on 11/20/23. The findings include: 1. Observation of the laboratory on 06/18/24 at 8 a.m. revealed the Sysmex XN 530 CBC w/Diff instrument (serial number 12245) used for patient testing. This instrument was new since the last survey date. 2. A review of patient test reports revealed that the first CBC from the Sysmex XN 530 occurred on 11/20/23 for patient sample number 23147634. 3. A review of the laboratory procedure for the Sysmex XN 530 revealed that the laboratory director approved the procedure on 12/01/23. 4. The laboratory director confirmed during the interview on 06/20/24 at 11:30 a.m. that the laboratory director did not approve the -- 2 of 3 -- procedure for the Sysmex XN 530 CBC instrument before patient testing, which began on 11/20/23. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 04/13/23. The facility was found NOT to be in compliance with the following 42 CFR PART 493, Requirements for Laboratories for the specialties/subspecialties for which it was surveyed. 42 CFR 493. 1250, Analytic systems ==================================== D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's Casper Report 155 and proficiency testing reports (PT), and staff interviews, the laboratory failed to ensure participation in one PT program for the year 2022 before switching to a different PT program for 2022 events two and three for testing performed on the Polymedco PathFast instrument. The findings include: 1. Observation of the laboratory on 04/13/23 at 8:30 am revealed the Polymedco PathFast instrument in use for performing patient testing for Troponin I, B-Type Natriuretic Peptide (NT- ProBNP), Creatine Kinase MB (CK-MB), and Fibrin Degradation Products (D- Dimer). 2. Review of the laboratory's Casper Report 155 and PT evaluation reports revealed PT participation with the College of American Pathologists (CAP) for 2022 event one, and American Proficiency Institute (API) for 2022 events two and three for the Polymedco PathFast chemistry instrument. 3. Interview with the lab director and technical consultant #2 on 04/13/23 at 6:00 pm confirmed the laboratory failed to ensure participation with one PT program before switching to a new PT program for testing performed on the Polymedco PathFast chemistry instrument in 2022. ==================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (Form CMS-209), review of the laboratory's proficiency testing (PT) records, and interview with technical consultant #2, the laboratory failed to ensure persons who perform patient testing on the Polymedco PathFast instrument used for performing cardiac testing participated in performance of proficiency testing in 2021, 2022, and 2023. The findings include: 1. Review of the Form CMS-209 revealed four personnel who perform patient testing in the laboratory in suite 300. 2. Review of the laboratory's proficiency testing attestation statements revealed the proficiency testing for the Polymedco PathFast instrument used for performing cardiac testing (CK-MB, Troponin I, NT-ProBNP and D-Dimer) was performed by testing person number two for six of seven PT events from 2021, 2022, and 2023. 3. Interview with technical consultant #2 on 04/13/23 at 6 pm confirmed the laboratory failed to ensure proficiency testing was performed by personnel who perform patient testing when testing person number two performed six of seven PT events for cardiac tests performed on the Polymedco PathFast instrument in 2021, 2022, and 2023. ==================================== 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: Citation Number One Based on review of coagulation quality control (QC) records for Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT), lack of records, patient test reports and staff interview, the laboratory failed to retain quality control printouts for the PT and PTT for a period of two years for QC performed on 01 /12/23. The findings include: 1. Review PT and PTT QC records revealed the QC is manually recorded on a log. 2. Request was made on 04/13/23 at 5 pm to the technical consultant #2 for instrument printouts for the PT and PTT QC recorded as the 2nd run (PM) performed on 01/12/23. No instrument printouts were maintained, no record was available. 3. Review of patient MRN 99734175 revealed PT and PTT reported on 01 /12/23 at 4:52 PM. 3. Interview with the lab director and technical consultant #2 on 04 /13/23 at 6 pm confirmed the laboratory failed to maintain instrument printouts for a period of two years for the PM QC performed for PT and PTT on 01/12/23. ==================================== Citation Number Two Based on observation of the laboratory, task demonstration, document request, and staff interviews, the laboratory failed to maintain quality control (QC) package inserts that come in each box of reagent for the Polymedco PathFast instrument for a period of two years. 1. Observation of the laboratory on 04/13/23 at 8:30 am revealed the Polymedco PathFast instrument in use for performing patient testing for Troponin I, B- -- 2 of 8 -- Type Natriuretic Peptide (NT-ProBNP), Creatine Kinase MB (CK-MB), and Fibrin Degradation Products (D-Dimer). The Biorad QC lot numbers in use for the D-Dimer assay were 74421 and 74424. 2. The lead testing person for chemistry was asked to demonstrate the method for entering the QC ranges in the PathFast instrument on 04 /13/23 at 5pm. She stated that each box of reagent for the PathFast instrument comes with a card with a unique reagent lot that is scanned into the PathFast when reagent lots are started. A package insert is also included that lists specific lot numbers of Biorad controls and the appropriate ranges that are specific to the reagent lot. The QC ranges are manually entered from the card into the PathFast instrument for each new lot of reagent that is received. 3. Request on 04/13/23 at 5pm for the QC package insert for the current reagent lot for the D-Dimer assay revealed the package insert was not available. 4. During an interview with the chemistry lead on 04/13/23 at 5:00 pm, the chemistry lead stated that the QC package insert for the D-Dimer assay had been discarded. She further stated that she tries to keep all the package inserts, but they may not all be kept. 5. Interview with the lab director and technical consultant #2 on 04/13/23 at 6 pm confirmed the laboratory failed to retain the QC package insert for the D-Dimer current reagent lot number. ==================================== 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, review of laboratory procedures, patient test records, environmental records, manufacturer package inserts, quality control records, lack of records, maintenance records and staff interviews, the laboratory failed to have an approved procedure for use of the Streck Diesse Erythrocyte Sedimentation Rate (ESR) instrument (Refer to D5407), failed to monitor the minimum/maximum temperature of the laboratory freezer (Refer to D5413), failed to appropriately label chemistry, urinalysis, hematology and coagulation controls and reagents with open date and corrected expiration date (Refer to D5415), failed to ensure complete blood count (CBC) controls were not used past their expiration date (Refer to D5417), failed to ensure the use of correct quality control ranges for the Troponin I analyte (Refer to D5469), failed to compare results between two urinalysis instruments (Refer to D5775), failed to have an effective quality assessment process in place for detection and correction of errors (Refer to D5793-Citation number one), and failed to have an effective process in place for review of quality control performed on the PathFast instrument (Refer to D5793 citation number two). ==================================== 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. -- 3 of 8 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, patient test records and staff interview, the laboratory failed to have an approved procedure for use of the Streck Diesse Mini Cube Erythrocyte Sedimentation Rate (ESR) instrument since beginning patient testing on 09/01/21 until the date of the survey on 04/13/23. The findings include: 1. Observation of the laboratory on 04/13 /23 at 8:30 am revealed the Streck Diesse Mini Cube instrument in use for performing patient ESR testing. 2. Review of the laboratory procedure manual revealed no approval of the procedure by the laboratory director. 3. Review of patient test reports revealed the first patient was reported on 09/01/21 (MRN 99776319). 4. Interviews with the lab director and technical consultant #2 on 04/13/23 at 6 pm confirmed the laboratory failed to have a procedure that was approved by the laboratory director for use of the Streck Diesse Mini Cube ESR instrument since patient testing began on 09 /01/21 until the date of the survey on 04/13/23. ==================================== 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 observation of the laboratory, review of freezer temperature records, and interview with the technical consultant, the laboratory failed to have a process in place for continuous monitoring of the freezer where the chemistry calibrators and controls were stored to ensure correct temperatures were maintained. The findings include: 1. Observation of the laboratory on 04/13/23 at 8:30 am revealed a freezer in use for storage of chemistry calibrators and controls. The label on the inside of the freezer indicated it was "frost proof." 2. Review of freezer temperature records revealed the minimum/maximum freezer temperatures were not recorded/monitored on a daily basis. 3. Interview with technical consultant #2 on 04/13/23 at 6 pm confirmed the freezer used for storage of chemistry reagents and controls goes through defrost cycles and the lab did not have a process in place for continuous monitoring of the freezer temperature to ensure the correct temperatures are maintained. ==================================== D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. -- 4 of 8 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer package inserts, and staff interview, the laboratory failed to ensure controls and reagents were appropriately labeled with open dates and/or corrected expiration dates on the date of the survey for 14 of 16 controls and reagents observed on the date of the survey (04/13 /23). The findings include: 1. Observation of the laboratory on 04/13/23 at 8:30 am revealed the following: ESR-Chex Plus QC material for use on the Diesse Mini Cube for erythrocyte sedimentation rate (ESR) instrument labeled with an open date of 04 /10/23 but no corrected open expiration date. Performance Verifier 1 and 2 used for performing QC on the Ortho Vitros 350 chemistry instrument (system ID #J27005008) labeled with an open date of 04/10/23, but no corrected open expiration date. Biorad Cardiac Marker and D-Dimer controls used for performing QC on the Polymedco PathFast (serial #1807D-D3219) (for performing D-Dimer, Troponin, CK- MB, and Pro-BNP chemistry tests) labeled with a date 04-10, but no corrected expiration date. Quantimetrix urine dipstick controls used for performing QC on the Siemens Clinitek Advantus Urine Dipstick instrument labeled with an open date of 04 /03/23 and a corrected expiration date of 11/30/23 that exceeded the manufacturer stability range (suite 300 lab only). Citrol controls (levels 1 and 3) used for performing QC on the Sysmex CA--600 instrument for PT and PTT - reconstituted for use with no open date and no corrected expiration date. Innovin used for performing Prothrombin Time (PT) reconstituted for use with no open date or corrected expiration date. 2. Review of control manufacturer package inserts revealed the following: ESR- Chex Plus controls used on the Diesse Mini Cube are good for 7 days after opening. Performance Verifier 1 & 2 used on the Ortho Vitros 350 chemistry instrument - stable for 7 days after reconstitution, except for ALKP, BuBc, Ca, and TBIL which are stable for 3 days after opening. Biorad Cardiac Marker controls are stable after thawing when stored at 2-8C for 20 days for all analytes except for NT-proBNP and Troponin I which are stable for 5 days. Biorad D-Dimer controls are stable for 15 days after opening when stored tightly capped at 2-8C. Quantimetrix Dipper Urinalysis controls are good for 3 months or 20 dips after opening, whichever comes first. Citrol control levels 1 and level 3 are good for 16 hours at 2-8C. Innovin stability after reconstitution when stored at 2-8C is 10 days, but may be shorter if kept onboard. 3. Interview with technical consultant #2 on 04/13/23 at 6 pm confirmed the laboratory failed to label controls and reagents with open dates and corrected expiration dates on the date of the survey (04/13/23). ==================================== 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the complete blood count (CBC) manufacturer package insert, and staff interview, the laboratory failed to ensure controls were not used past the expiration date from 03/04/23 to the date of the survey on 04/13/23. The findings include: 1. Observation of the laboratory on 04/13/23 at 8: 30 am revealed the Sysmex XS1000i CBC instrument in use for patient testing. Also observed were three levels of hematology controls being used for performing QC on -- 5 of 8 -- the CBC instrument (Lot numbers 30380804, 30380805, 30380806). The controls were labeled with 02/17. 2. Review of the QC package insert revealed the following statement: "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8C. 3. Interview with technical consultant #2 on 04/13/23 at 6:30 pm confirmed the date of 02/17 was the date the vials were opened and the laboratory used the controls past the expiration date from 03/04/23 to the date of the survey on 04/13/23. ==================================== D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, task demonstration, review of quality control (QC) files for the Polymedco PathFast instrument, and staff interviews, the laboratory failed to have a process in place to verify the correct QC ranges for the Troponin I analyte were used from 03/17/23 to 04/13/23. The findings include: 1. Observation of the laboratory on 04/13/23 at 8:30 am revealed the Polymedco PathFast instrument in use for performing patient testing for Troponin I, NT-ProBNP, CK-MB, and-Dimer. The Biorad QC lot numbers observed in use for Troponin I were 67695 for level 1B and 67693 for level 3. The lot number of reagent observed for Troponin I was E265. 2. The lead testing person for chemistry was asked to describe the method for entering the QC ranges in the instrument on 04/13/23 at 5 pm. She stated that each box of reagent for the PathFast instrument comes with a card with a unique reagent lot that is scanned into the PathFast. A package insert is also included that lists specific lot numbers of Biorad controls and the appropriate ranges that are specific to the reagent lot. The ranges are manually entered from the package insert into the PathFast instrument when each new lot of reagent is started. 3. Review of the laboratory's current QC ranges in use for the Troponin I analyte for reagent lot E265 when compared to the package insert revealed the following: Range in use for level 3 QC lot 67693 = 15.8-29.3 Correct range for level 3 QC lot 67693 = 18.8 - 34.9 4. Staff interviews with the lab director, technical consultant #2 and chemistry lead on 04/13 /23 at 6 pm confirmed the laboratory failed to ensure the use of correct QC ranges for the Polymedco Pathfast instrument for the Troponin I analyte from the time lot E265 started on 03/17/23 until the date of the survey on 04/13/23. ==================================== D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) -- 6 of 8 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of records and staff interview, the laboratory failed to compare results between two moderately complex urinalysis instruments in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 04/13/23 at 8:30 am revealed two Siemens Clinitek Advantus moderately complex urine instruments in use for performing urine dipstick analysis -- one located in the main laboratory in suite 300 and one located in the urology clinic on the 5th floor. 2. There were no records available for twice a year comparison of results between the two instruments. 3. Interview on 04/13/23 at 6 pm with the lab director confirmed the laboratory did not perform twice a year comparison of results between the two urinalysis instruments in 2021, 2022, and 2023. ==================================== D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 for two consecutive proficiency testing (PT) events for total cholesterol resulting in the first unsuccessful PT occurrence for the total cholesterol analyte. (Refer to 2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 -- unsuccessful performance. 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 2022 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive test event for the total cholesterol analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory total cholesterol scores: 2022 event one: 60% 2022 event two: 60% 2. Review of the laboratory's 2022 event one PT evaluation report revealed unacceptable scores for the total cholesterol for sample numbers CHM- 02 and CHM-03 resulting in an overall score of 60%. 3. Review of the laboratory's 2022 event two PT evaluation report revealed unacceptable scores for the total cholesterol for sample numbers CHM-06 and CHM-10, resulting in an overall score of 60% and the first unsuccessful PT occurrence for the total cholesterol analyte. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation of the laboratory, review of the validation studies performed for the Polymedco Pathfast instrument, the laboratory procedure manual, and interview with the laboratory director, the laboratory failed to follow the procedure for validation of instrument/methods in 2018. The findings include: 1) Observation of the laboratory on August 12, 2019 at 9:00 am revealed the Polymedco Pathfast instrument in use for patient testing for N-terminal-pro B-type Natriuretic Peptide (NT-proBNP). 2) Review of the validation studies performed in April 2018 for the Polymedco Pathfast NT-proBNP revealed no normal range study was performed. 3) Review of the laboratory procedure titled "INSTRUMENT/METHOD VALIDATION (NON- WAIVED TESTING) CHECKLIST" revealed the following statements: "Instrument Validations must be performed whenever a new instrument is installed, added relocated or when a demo/loaner instrument is placed in the laboratory. Laboratories must verify the following:" "Reference Ranges (Normal Values)". 4) Interview with the laboratory director on August 12, 2019 at 5:30 pm confirmed the laboratory failed to follow the procedure for instrument/method validation in 2018 for the NT-proBNP performed on the Polymedco Pathfast instrument when it did not perform a normal range study. Patient testing on the instrument began May 2018. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 -- 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 review of the laboratory procedure manual, the laboratory's calibration and calibration verification records for the Polymedco Pathfast N-terminal-pro B-type Natriuretic Peptide (NT-proBNP), and interview with the laboratory director, the laboratory failed to perform calibration verification at least every 6 months for the NT pro-BNP performed on the Polymedco Pathfast instrument in 2018 and 2019. The findings include: 1) Review of the laboratory procedure for the Polymedco Pathfast NT-proBNP revealed that calibration is performed using only two levels of calibrators. 2) Review of the laboratory's calibration and calibration records revealed that calibration is performed using only two levels of calibrator and the calibration verification due October 2018 and April 2019 was not performed. 3) Interview with the laboratory director on August 12, 2019 at 5:30 pm confirmed the laboratory failed to perform calibration verification for the Polymedco Pathfast NT-proBNP assay at least every six months to include a low, mid, and high level in 2018 and 2019. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance (QA) plan, complete blood count (CBC) quality control (QC) data, and interview with the laboratory director, the laboratory failed to follow the policy for review of CBC quality control data in 2018 and 2019. The findings include: 1) Review of the laboratory's quality assurance plan revealed that "Records of our quality control and maintenance are dated and initialed by the Technical Consultant and by the Laboratory Director each month." 2) Review of the laboratory's CBC quality control reports for lot number 7325 and 8352 revealed -- 2 of 4 -- the following: Lot number 7325 QC data from February 1, 2018 to February 9, 2018 had not been printed for review by the laboratory director; Lot number 8352 QC data from March 1, 2019 to March 8, 2019 had not been printed for review by the laboratory director. 3) Interview with the laboratory director on August 12, 2019 at 5: 30 pm confirmed the laboratory did not follow the QA plan for monthly review of quality control data in 2018 and 2019. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of validation records for the Polymedco Pathfast instrument, testing personnel records, patient number twenty one test report, and interview with the laboratory director, the laboratory director failed to ensure testing personnel number three had documented training for performing testing for the N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) on the Polymedco Pathfast instrument. 1) Observation of the laboratory on August 12, 2019 at 9:00 am revealed the Polymedco Pathfast instrument in use for patient testing for NT-proBNP. 2) Review of the validation records for the Polymedco Pathfast instrument revealed the laboratory began using the Polymedco Pathfast instrument for patient testing in May 2018. 3) Review of testing personnel records revealed no documented training for testing personnel number three for use of the Polymedco Pathfast instrument. 4) Review of patient number twenty-one test report revealed patient testing for NT- proBNP performed by testing personnel number three on April 19, 2019. 5) Interview with the laboratory director on August 12, 2019 at 5:30 pm confirmed the laboratory director failed to ensure testing personnel number three had documented training prior to performing patient testing for NTproBNP. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's procedure manual, the laboratory's quality control records, patient numbers twenty-two and twenty-three test report, and interview with the laboratory director, testing personnel failed to follow the individualized quality control plan (IQCP) for the D-dimer test in 2018. The findings include: 1) Observation of the laboratory on August 12, 2019 at 9:00 am revealed the Alere Triage meter in use for patient testing for D-Dimer. 2) Review of -- 3 of 4 -- the laboratory's IQCP for the D-Dimer test revealed the following: "Perform 2 levels of QC with each new cartridge lot #, each new shipment received date or every 30 days." 3) Review of the laboratory's January and February 2018 quality control records for the D-dimer test revealed lot number W63228 in use in January and February 2018. The 30 day quality control due on February 1, 2018 was not performed. 4) Review of patient numbers twenty two and twenty three test report revealed testing for D-dimer performed on February 21, 2018 and February 27, 2018 respectively, during the gap in quality control performance. 5) Interview with the laboratory director on August 12, 2019 at 5:30 pm confirmed that testing personnel failed to follow the IQCP procedure for the D-dimer test performed on the Alere Triage instrument in 2018 with patient testing performed. -- 4 of 4 --