Glenside Medical Associates Llc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Glenside Medical Associates on 02/07/24 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F. R. 493-1250 Condition: Analytic Systems. 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 the review of proficiency testing (PT) records, lack of documentation, and an interview, the lab director and testing personnel (TP) failed to review and sign one of three attestation statements reviewed for calendar year 2023. Findings include: 1. Review of the three 2023 College of American Pathologists (CAP) hematology PT records revealed lack of documentation for the following: 2023 FH16 C Hematology event- Attestation statement- no signature by the lab director and testing personnel. 2. An exit interview with testing personnel and lab consultant on 02/07/24 at 1700 confirmed the findings. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the review of Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), CASPER Survey Summary (Report 0096D), proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to retain documentation of participation for two of two 2022 hematology events reviewed. Findings include: 1. Review of the CMS 116 form, the CASPER Report 0096D, and the College of American Pathologists (CAP) 2023 PT records revealed the laboratory performs Complete Blood Count with automated White Blood Cell differential (CBC with WBC Diff) patient testing and participates in the CAP PT program. In addition, the CASPER Report 0096D revealed scores submitted to CMS for events B and C in 2022. 2. Review of the laboratory's available CAP PT records revealed lack of documentation of participation in the CAP FH16 B and C events in 2022 to include the PT program report forms, instrument printouts, attestation statements and result reviews for the two events. The inspector requested to review the documents. The laboratory could not locate the documents for review. 3. An exit interview with the testing personnel and lab consultant on 02/07/24 at 1700 confirmed the findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to review and evaluate one of two urinalysis sediment microscopy events in calendar year 2023. Findings include: 1. Review of the College of American Pathologists (CAP) PT records revealed the laboratory participates in the CAP Clinical Microscopy PT module. The review revealed participation and review of results for the first event in 2023, CMA- A and CAP PT report forms for the second event in 2023, CMA-B. In addition, the review revealed lack of documentation of results from CAP PT program for CMA-B and the laboratory's review or assessment of the second event. 2. The inspector requested to review the CAP PT CMA-B event results and laboratory's assessment for the event. The documentation was not available for review. 3. An exit interview with testing personnel and lab consultant on 02/07/24 at 1700 confirmed the findings. 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 -- 2 of 5 -- 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 the review of manufacturer storage requirements, temperature records, calibration verification records, available quality control (QC) records, electronic medical records (EMR), lack of documentation, and an interview, the laboratory failed to: 1. Ensure the freezer temperatures were within manufacturer's acceptable range for the Triage Total 5 quality control materials for 26 of 62 days reviewed. Refer to D5413. 2. Perform and assess the accuracy, precision and reference range of the creatine kinase-myocardial band (CK-MB), myoglobin, troponin I and D-Dimer analytes assayed on the Quidel Triage MeterPro. Refer to D5421. 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 the review of manufacturer storage requirements, temperature records, and an interview, the laboratory failed to ensure the freezer temperatures were within manufacturer's acceptable range for the Triage Total 5 quality control materials for 26 of 62 days reviewed (December 2023 and January 2024). Findings include: 1. Review of manufacturer storage requirements for the Triage Total 5 quality control materials revealed the materials must be stored at freezer temperatures of equal to or less than -20 degrees Celsius. 2. Review of daily freezer temperature logs for December 2023 and January 2024 revealed that the freezer temperature recorded as warmer than -20 degrees Celsius for: 11 days in December 2023 and 15 days in January 2024. 3. An exit interview with testing personnel and lab consultant on 02/07/24 at 1700 confirmed the findings. 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on the review of calibration verification records, available quality control (QC) records, electronic medical records (EMR), lack of documentation, and an interview, the laboratory failed to perform and assess the accuracy, precision and reference range of the creatine kinase-myocardial band (CK-MB), myoglobin, troponin I and D-Dimer analytes assayed on the Quidel Triage MeterPro prior to reporting patients at the date of the survey on 02/07/24. Finding include: 1. Review of available calibration verification records revealed procedures performed on 11/10/23 for the CK-MB, myoglobin, troponin I and D-Dimer analytes using the Quidel Triage MeterPro. In addition, testing of levels 1 and 2 of the Triage Total 5 QC materials were performed on 11/10/23 and 12/05/23. The documentation lacked review by the lab director. 2. An interview with testing personnel #1 and the lab consultant on 02/07/24 at 1543 revealed the lab began patient testing for the above-specified analytes 01/04/24. Review of patient test data in the Athena EMR revealed one patient assayed and reported for the CK-MB, myoglobin, and troponin I analytes on 01/12/24. 3. The inspector requested to review the assessment, review and approval of the accuracy, precision and reference ranges for the above-specified analytes by testing personnel and lab director prior to testing patients. No additional documentation was available for review. 4. An exit interview with testing personnel and lab consultant on 02/07/24 at 1700 confirmed the findings. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on the review of calibration verification records, available quality control (QC) records, electronic medical records (EMR), lack of documentation, and an interview, the laboratory director failed to ensure the accuracy, precision and reference range verification was performed and approved prior to resulting patients for the creatine kinase-myocardial band (CK-MB), myoglobin, troponin I and D-Dimer analytes at the date of the survey on 02/07/24. Cross Reference D5421. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, policy and procedures (P&P), lack of documentation, and an interview, the technical consultant failed to provide documentation of annual -- 4 of 5 -- competency assessments for two of two TP performing patient testing in the calendar year 2022. Findings include: 1. Review of the CLIA CMS 209 Form revealed the lab director performs the duties of technical consultant and three TP. 2. Review of TP records and an interview with TP #1 and the lab consultant on 02/07/24 at 1543 revealed that TP #2 and #3 performed patient testing up to November 1, 2023. The inspector requested to review documentation of competency assessments performed in 2022 for TP #2 and #3. The documentation was not available for review. 3. Review of the P&P revealed a quality assurance (QA) program that included the following statements, "Personnel Assessment- The laboratory uses a lab personnel evaluation form to document performance of all lab personnel annually and whenever there is a problem with competency." "Quality Assurance Reviews- the lab retains all quality assurance records for two years." 4. An exit interview with testing personnel and lab consultant on 02/07/24 at 1700 confirmed the findings. -- 5 of 5 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Glenside Medical Associates PC on April 7, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS- CoV-2 (COVID-19) testing and is in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to verify twice annually accuracy of urinalysis sediment microscopy in calendar year 2021. Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) Clinical Microscopy module PT records (five events reviewed: 2020 Events A-B, 2021 Events A-B, 2022 Event A) revealed the following unsatisfactory score: 2021 Event A - scored as Unacceptable 34% (USP-01, USP-03 scored as failed). The inspector requested to review documentation of

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Glenside Medical Associates, PC on September 25, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: 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 a tour, review of manufacturer's reference guide, daily temperature logs, and an interview with Testing Personnel A (TP A), the laboratory failed to monitor the daily relative humidity percent (RH%) to ensure manufacturer's operating requirements were followed for the Beckman Coulter AcT diff analyzer utilized in patient hematology testing from February 2018 to September 2019. Findings include: 1. During a tour of the laboratory, the surveyor noted a Beckman Coulter AcT diff hematology analyzer in use for patient hematology Complete Blood Count (CBC) testing. 2. Review of the manufacturer's reference guide for instrument specifications revealed the Beckman Coulter AcT diff humidity requirement was 20% to 85% without condensation. 3. Review of the daily temperature logs from 02/01/18 to 09/25 /19, revealed no record of laboratory humidity monitoring for twenty (20) of the 20 months reviewed. The surveyor requested documentation of the laboratory humidity from 02/01/19 to 09/25/19. The laboratory provided no documentation to review. 4. In 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 -- an exit interview with TP A at approximately 12:00 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Glenside Medical Associates PC on January 23, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of proficiency testing records, the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), and an interview, the laboratory failed to rotate hematology proficiency testing among all personnel performing patient testing in calendar year 2016. Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) 2016 and 2017 hematology proficiency testing (PT) records, a total of six (6) events, revealed: Testing Personnel A performed testing and signed attestation for the following five (5) events: 2016 Hematology Event A, 2016 Hematology Event B, 2016 Hematology Event C, 2017 Hematology Event B, 2017 Hematology Event C, and Testing Personnel B performed and signed the attestation for 2017 Hematology Event A. (See attached Testing Personnel Code Sheet) 2. Review of the CMS 209: laboratory personnel form revealed a total of three (3) laboratory testing personnel performing patient testing during the timeframe of the PT events reviewed. 3. In an interview with the general supervisor at approximately 1:30 PM on January 23, 2018, it was confirmed that the laboratory failed to rotate hematology proficiency testing among all personnel performing patient testing in calendar year 2016. 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 -- D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the laboratory policies and procedure manual, patient test logs, and interviews, the laboratory did not follow their written policy that defined specimen identification/labeling criteria for all specimens collected and submitted for laboratory testing during calendar year 2016 up to the date of survey on 1/23/18. Findings include: 1. During a laboratory tour with the general supervisor at approximately 11:30 AM on January 23, 2018, the inspector noted patient urine specimen cups in a bin located on the laboratory test bench. Each of the specimen cups had been labeled by a handwritten patient last name. No other patient identifiers were found on the patient specimens. The general supervisor stated that the laboratory did accept and routinely process samples labeled with last name only. The inspector inquired if the laboratory had a protocol in place to distinguish specimens in the event that the staff had collected multiple samples with the same last name simultaneously. The general supervisor indicated that the lab did not have a protocol in place. 2. Review of the laboratory procedure manual revealed a written policy which defined specimen identification/labeling criteria for specimens collected and submitted for laboratory testing. The policy states: "Label sample with patients full name, ID number, and date." 3. Review of the patient test logs revealed that the laboratory and nursing staff had collected, tested, and resulted: One thousand six hundred ninety-four (1,694) urinalysis/microscopy tests in calendar year 2016, One thousand one hundred fifty-five (1,155) urinalysis/microscopy tests from 01/3/17 to the date of the survey, for a total of two thousand eight hundred forty-nine (2,849) patient samples. 4. In an interview with the general supervisor at approximately 1:30 PM on 1/23/18, it was confirmed that the laboratory did not follow their written policy of specimen identification/labeling criteria for specimens collected and resulted for urinalysis /microscopy in 2016, and 2017 up to the date of the survey. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration records, quality control (QC) policy, patient test logs, and an interviews, the laboratory failed to document calibration procedures for Complete Blood Count (CBC) testing according to the laboratory's written policy from September 28, 2017 through October 25, 2017 while reporting eighty-five (85) patient CBC test results. Findings include: 1. Review of the laboratory's 2016 and 2017 calibration records for the Beckman Coulter AcTdiff hematology analyzer revealed CBC calibration documentation on the following dates: 3/21/16, 9/14/16, 3/28/17, and 10/25/17. The lab inspector requested calibration records for the time period of September 28, 2017. No calibration documentation was available for the timeframe requested. The general supervisor stated that the six (6) month calibration was missed on 9/28/17 due to short staffing issues and analyzer issues. 2. Review of the laboratory's hematology QC policy revealed instructions stating "calibration is required every 6 months". 3. Review of the laboratory's patient test log revealed eighty-five (85) patient CBC test results were reported during the timeframe of the calibration lapse outlined above. 4. In an interview with the general supervisor at approximately 1:30 PM it was confirmed that the laboratory failed to document calibration procedures for CBC testing on the Beckman Coulter AcTdiff analyzer according to the QC policy in 2017. -- 3 of 3 --