Physicians Associates Pa

Summary Statement of Deficiencies D0000 A recertification survey conducted from 12/20/2022 to 12/22/2022 found the PHYSICIANS ASSOCIATES PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. Cited the following Conditions: -D2000 Enrollment and Testing of Samples. -D2016 Successful Participation. -D6000 Moderate Complexity Laboratory Director. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to enroll in a Proficiency Testing (PT) program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for the specialty of Hematology during first and second event of 2022. Findings include: -Review of College of American Pathologists (CAP) PT records revealed that the laboratory had no results for PT for the Hematology Specialty for the first and second events of 2022. During an interview on 12/20/2022 at 1:30 PM. the Office Manager confirmed that the facility failed to enroll in PT for 2022 for the events of reference. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- 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 record review and staff interview, the laboratory failed to have attestation signed by testing person (TP) and laboratory director (LD) for 1 out of 4 events reviewed for hematology specialty in 2021 and 2022. Findings include: -Review of College of American Pathologists (CAP) Proficiency Testing (PT) records for years 2021 and 2022 revealed that the laboratory failed to have a signed attestation for the second event of Hematology of 2021 During an interview on 12/20/2022 at 1:45 PM, the office manager confirmed that the laboratory failed to have a signed attestation for the event of reference. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's Proficiency Testing records for 2022, the laboratory did not have successful performance in Proficiency Testing (PT) for analytes in the specialty of Hematology. Refer to D2130. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) Hematology Proficiency Testing (PT) results and interview, the laboratory failed to submit PT results in the -- 2 of 7 -- specified timeframe for third event of 2021 for the specialty of Hematology resulting in a score of 0% for all Hematology analytes. Findings include: Review of CAP Hematology PT records revealed that the laboratory failed to submit the results for the third event of 2021 on time resulting in a score of 0 % for Hematology Specialty, Cell Identification or White Blood Differential, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cells and Platelets. During an interview on 12/20/2022 at 1:00 PM, the office manager confirmed that the laboratory failed to submit on time the results for the third event of 2021. 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. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) Hematology Proficiency Testing (PT) results and interview, the laboratory did not have successful performance in PT for analytes in the specialty of Hematology. Findings include: Review of CAP Hematology PT records revealed that the laboratory had an unsatisfactory score of 0% for Hematology Specialty, Cell Identification or White Blood Differential, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cells and Platelets in the third event of 2021. The laboratory did not have results for first and second event of 2022 and for the third event of 2022 had 0% score for Hematocrit and Hemoglobin with an overall percentage of 67% in the Hematology specialty resulting in a unsatisfactory result for this event. The PT overall evaluation for the laboratory performance was Unsuccessful for Hematocrit, Hemoglobin and the Specialty of Hematology. Refer to D2127. During an interview on 12/20/2022 at 1:10 PM, the office manager confirmed that the laboratory had the unsuccessful result for PT 2022. 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 record review and interview with office manager, the laboratory failed to retain daily Quality Control (QC) records for 14 out of 24 months reviewed (2021 and 2022). Findings include: Review of QC records for 2021 and 2022 revealed that the laboratory failed to have the records for 2021 and for September and October 2022. During an interview on 12/20/2022 at 1:35 PM, the office manager confirmed that the laboratory failed to have onsite during the survey the daily QC records of reference. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain 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. -- 3 of 7 -- This STANDARD is not met as evidenced by: Based on record review and interview with office manager, the laboratory failed to retain daily maintenance for Coulter Ac T diff analyzer records for 18 out of 24 months reviewed (2021 and 2022). The laboratory failed to have room temperature and humidity records for 18 out of 24 months reviewed (2021 and 2022). Findings include: Review of Coulter Ac T diff analyzer maintenance records for 2021 and 2022 revealed that the laboratory failed to have the records of year 2021 and from January to July of year 2022. Review of room temperature and humidity records revealed that the laboratory failed to have on site the records for 2021 and for January to July of 2022. During an interview on 12/20/2022 at 1:40 PM, the office manager confirmed that the laboratory failed to have onsite maintenance, room temperature and humidity records of reference. 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, record review and interview, the laboratory had expired controls in use from 12/05/2022 to 12/20/2022. Findings include: -During the laboratory tour on 12/20/2021 at 11:30 AM, the surveyor observed that the laboratory was using Coulter 4C-ES Cell Control with Lot numbers: 069000, 079000 and 089000 and the vials were labeled with open date of 10/24/2022. The open vials have been in use for 50 days. -Review of the Coulter 4C-ES Cell Control user instructions revealed that used controls had an expiration date of 35 days after opening. -Review of patient records revealed that the laboratory tested patients using the expired controls in the following dates: 12/05/2022 tested 1 patient, 12/06/2022 tested 1 patient, 12/13/2022 tested 2 patients, 12/14/2023 tested 2 patients, 12/15/2022 tested 1 patient and on 12/19/2022 tested 3 patients. In total 10 patients were tested with the expired controls. During an interview on 12/20/202 at 12:30 PM the officer manager confirmed the use of the expired controls for the days listed above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected -- 4 of 7 -- 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 record review and interview with office manager, the laboratory failed to have documentation of the calibration verification for the Coulter Ac T Diff complete blood counter at least every 6 months from 01/01/2021 to 12/19/2022. Findings include: -Review of the Coulter Ac T Diff Analyzer records during 2021 and 2022 revealed that the laboratory performed calibration on 12/15/2021 and 09/27/2022. No other calibration records found. During an interview on 12/20/2022 at 12:30 PM, the office manager confirmed that the laboratory failed to have documentation of calibration verification at least every six month for 2021 and 2022. 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 lack of records and interview, the Quality Assessment (QA) failed to document the deficiency of failure to submit Proficiency Testing (PT) results for third event of 2021 and to review the results. Failed to do

Summary Statement of Deficiencies D0000 A recertification survey was completed on 12/21/2020 to 12/22/2020 at PHYSICIANS ASSOCIATES PA. The facility was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Condition was cited: -D3000 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure that the testing laboratory reported positive and negative COVID-19 results to the Florida Health Department from June 2020 to December 2020. (See 3009 ) D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure that the testing laboratory reported positive and negative COVID-19 results to the Florida Health Department from June 2020 to December 2020. Findings Included: No records available for documentation of reports to the Florida Health Department of COVID- 19 for positive and negative results for Sofia 2 SARS Antigen FIA and Healgen 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 -- Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette . Review of FDOH Emergency Rule 64DER20-26 (64D-3.029) of April 10th 2020, revealed for COVID- 19; the timeframe is immediately and had special reporting requirements. Results should be reported and accompanied by any testing conducted (positive and negative). For laboratories performing electronic laboratory reporting as described in subsection 64D-3.031 (5). F.A.C., all test results (positive and negative) are to be submitted, including screening test results (positive and negative). During an interview on 12/21 /2020 at 2:56 pm with the testing personnel confirmed that the laboratory does not have records of the notification to the Florida Health Department of positive and negative results . D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette from 6/4/2020 to 12/21/2020 Findings Included: Review of COVID-19 External Quality Control for Healgen revealed negative and positive controls not documented from 6/4/2020 to 12/21/2020. Review of COVID-19 testing log revealed Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette in use 6/4/2020 to 12/21/2020. During an interview on 11-10-2020 at 4:49pm , the testing person confirmed failure to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette from 6 /4/2020 to 12/21/2020. 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 record review and interview, the laboratory director (LD) failed to review and sign the validation for the Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette used for COVID-19 testing from 6/4/2020 to present. Finding Included : Review of the Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette Validation revealed LD did not sign and review the equipment for COVID-19 PCR Testing before use in 6/4/2020 to present . An interview on 12/21/2020 at 2:56 pm, the testing person confirmed the laboratory director (LD) failed to review and sign the -- 2 of 3 -- validation for the Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette used for COVID-19 testing from 6/4/2020 to present. -- 3 of 3 --

Summary Statement of Deficiencies 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 CAP (College of American Pathologists) proficiency testing for two-year period (2016 to 2018), and interview with testing person #1, the laboratory failed to rotate proficiency testing (PT) events to include all testing personnel who perform patient testing, for 6 of 6 events reviewed for hematology and urine hCG (Human chorionic gonadotropin) tests. The findings include: On September 26, 2018 at 12:30pm surveyor reviewed CAP proficiency testing record for six events (2016- 3rd event, 2017-1st, 2nd, 3rd events, 2018-1st and 2nd event). 1) Hematology PT showed that testing person #1 performed PT for 2016- 3rd event, 2017-1st, 2nd, 3rd events. For 2018-1st and 2nd event, two testing personnel (#1 and #2) had signed the CAP attestation forms for each test event, indicating testing personnel #1 and #2 both participated in same testing events. 2) Urinalysis and urine hCG PT showed that testing person #1 performed proficiency tests for year 2016 and 2017-1st event. For 2017 2nd event, 2018 1st and 2nd events two testing personnel (#1 and #2) had signed the CAP attestation forms for each test event, indicating testing personnel #1 and #2 both participated in same testing events. During an interview on September 26, 2018, at 4:45pm, the testing person#1 confirmed that: a) the testing person #1 and #2 performed both hematology, urinalysis, urine hCG patient testing but only testing person #1 performed hematology PT tests for 2016- 3rd event, 2017-1st, 2nd, 3rd events and performed urinalysis and urine hCG proficiency tests for year 2016 and 2017-1st event. b) For 2018-1st and 2nd event- hematology and for 2017 2nd, 2018 1st and 2nd events-urinalysis, urine hCG, two testing personnel (#1 and #2) had signed the CAP attestation forms for each test event, indicating testing personnel #1 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 -- and #2 both participated in same testing events. c) Testing person #1 did not perform hematology proficiency testing independently for 1st and 2nd event 2018 and urinalysis, urine hCG proficiency testing independently for 2nd event 2017, 1st and 2nd event of 2018. d) Testing person #2 did not perform hematology, urinalysis, urine hCG proficiency testing independently from year 2016 to 2018. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of CAP (College of American Pathologists) proficiency testing for two-year period (2016 to 2018), and interview with testing person #1, the laboratory failed to score at least 80% for cell identification (white blood cell differential) in the specialty of hematology in one (2017, 1st event) out of six (2016-3rd, 2017-1st, 2nd, 3rd, 2018-1st, 2nd) testing events reviewed. The findings include: On September 26, 2018 at 12:30pm surveyor reviewed CAP proficiency testing records for six test events (2016-3rd event, 2017-1st, 2nd, 3rd events, 2018-1st and 2nd event). It showed that laboratory scored 80% for cell identification (white blood cell differential) for the 1st event-2017. During an interview on September 26, 2018, at 4:45pm, the testing person #1 confirmed the cell identification (white blood cell differential) proficiency testing failure. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and the interview with the testing person #1, the laboratory failed to provide the safety and sanitary conditions to the testing personnel. The findings include: Observation on September 26, 2018 at 1) 10:30am surveyor observed the laboratory personnel - used gloves in regular trashcan. 2) 3:30pm surveyor observed another pair of the laboratory personnel - used gloves in regular trashcan. During an interview on September 26, 2018, at 4:45pm the testing person#1 confirmed both the findings that the regular trashcan had laboratory personnel - used gloves from hematology specialty at 10:30am and again at 3:30pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of CAP (College of American Pathologists) proficiency testing results for two-year period (2016 to 2018) and interview with testing person #1, the -- 2 of 4 -- laboratory failed to have documentation for