David Oneil Md Pa

Summary Statement of Deficiencies 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 procedure and temperature record review and interview with the technical consultant (TC), the laboratory failed to ensure that room and refrigerator temperatures were recorded every day. Findings: 1. The procedure titled "Instrument Maintenance Program" stated that "Many of the devices and small analyzers will operate between 16-35C or 61-95F. Reagents and controls are refrigerated between 2- 8C or 35-46F when not in use. Record all temperature taken on the daily worksheet book." 2. Review of the daily worksheets from 07/22/2023-10/31/2024 showed that the refrigerator temperature was not recorded 1 of 15 days recorded in 01/2024 (on 01 /24/2024) and the room and refrigerator temperature were not recorded 1 of 22 days recorded in 02/2024 (02/19/2024), 2 of 19 days recorded in 10/2023 (10/24/2023 and 10/30/2023), and 2 of 17 days recorded in 11/2023 (11/16/2023 and 11/22/2023). 3. During the exit interview on 12/16/2024 at 1:15 PM, the TC confirmed that the room and refrigerator temperatures were not consistently recorded on the daily worksheets. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- 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 record review and interview with the technical consultant (TC), the laboratory failed to ensure quality control (QC) reagents for Rhesus (Rh) factor were not used beyond their expiration date. Findings: 1. The laboratory documented daily Rh QC results on a daily worksheet that included the lot numbers and expiration dates of the QC reagents. 2. Daily worksheets for 01/30/2024 and 01/31/2024 listed a positive QC lot number 198790 and negative QC lot number 398790 that both expired on 01/26/2024. A total of 3 patients were tested for Rh factor over the two days. 3. During the exit interview on 12/16/2024 at 1:15 PM, the TC confirmed that expired QC reagents were used on 01/30/2024 and 01/31/2024. 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 procedure and record review and interview with the technical consultant (TC), the laboratory failed to document Rhesus (Rh) factor quality control (QC) results for 1 of 19 days of testing in 10/2023. Findings: 1. The procedure titled "Rh Typing: Tube Method" stated that "In this Lab, both levels of quality control are tested just like patient samples at the beginning of each day when patient samples are tested. Results of controls are documented on a worksheet. Patient results are not reported unless the results for both levels of controls are acceptable." 2. The laboratory documented daily Rh QC results on a daily worksheet. 3. Review of daily worksheets showed that QC results from 1 of 19 days in 10/2023 (10/30/2023) were not documented. 4. During the exit interview on 12/16/2024 at 1:15 PM, the TC confirmed that Rh QC results were not documented as performed in 1 of 19 days in 10 /2023. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on procedure and record review and interview with the technical consultant (TC), the laboratory failed to document results from repeat Rhesus (Rh) factor testing. -- 2 of 3 -- Findings: 1. The procedure titled "Rh Typing: Tube Method" stated that "If the test result is negative or doubtful repeat the testing to confirm the negative agglutination before reporting the result." 2. All patient test results were documented on a daily worksheet. 3. Review of the daily worksheets from 07/22/2023-10/31/2024 showed that testing personnel did not document that negative test results were confirmed by repeat testing. There were a total of 31 negative patient results documented in the reviewed timeframe. 4. During the exit interview on 12/16/2024 at 1:30 PM, the TC confirmed that testing records did not show that negative results were repeated to confirm the negative agglutination before reporting patient results. -- 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 the proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that the PT samples were routinely performed with the laboratory's regular patient workload. Findings: 1. The blood banking PT records for 2021 and 2022 (six events) were reviewed. Two of six events showed that the PT samples were tested without patient and quality control (QC)specimens. 2. The five PT samples from the third event of 2022 were tested on 09 /16/2022. The patient logs show that no patients were tested that day and the QC logs show that no QC was tested that day. 3. The five PT samples from the first event of 2022 were tested on 02/03/2022. The patient logs show that no patients were tested that day and the QC logs show that no QC was tested that day. 4. During the survey on 02/15/2023 at 10:45 AM, the TC confirmed that the blood banking PT samples were not being routinely performed with the laboratory's regular patient workload along with the QC materials to ensure accurate and reliable test results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on procedure manual and quality control (QC) record review and interview with the technical consultant (TC), the laboratory did not follow manufacturer's instructions for performing waived hemoglobin testing with the HemoCue Hb 201 analyzer. Findings: 1. The "HemoCue Hb201 Hemoglobin Procedure" states "After opening, QC material is good for only 30 days at RT or 60 days when refrigerated or until the printed manufacturer's expiration date (whichever comes first)." 2. HemoCue hemoglobin QC record review was performed for April and September of 2019 and 2020. The laboratory records the "Open Vial Expiration Date" of the HemoCue QC on a daily QC log. 3. The "Open Vial Expiration Date" was not documented 12 of 14 days in April 2019; 12 of 15 days in September 2019; 13 of 16 days in April 2020; and 9 of 19 days in September 2020. 4. On 4/23/2019 and 4/24/2019 expired HemoCue controls were run (Low Control, Lot Number 82665, expiration date 4/22 /19 and High Control, Lot number 83467, expiration date 4/22/19). 7 patients were run on each of these days. 5. During an interview on 7/15/2021 at 2:00 PM, the TC confirmed that the laboratory did not follow the manufacturer's instructions for performing waived hemoglobin testing with the HemoCue Hb 201 analyzer. 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 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 -- laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that all the testing personnel who tested patient samples performed the PT. Findings: 1. The laboratory currently has 5 testing personnel listed on the "Laboratory Personnel Report (CMS-209)" who perform Chemistry (serum hCG pregnancy) and Nonchemistry (D (Rho) Typing) testing. 2. A review of Chemistry PT attestation worksheets from 2019 and 2020 showed that PT was performed by the same testing person in 5 of 6 events; and 3. A review of Nonchemistry PT attestation worksheets from 2019 and 2020 showed that PT was performed by the same testing person in 3 of 6 events. 4. During an interview on 7/15 /2021 at 2:00 PM, the TC confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. 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 quality control (QC) record review and interview with the technical consultant (TC), the laboratory failed to ensure that hematology and Rh factor blood typing QC was not used after it exceeded its expiration date. Findings: 1. The laboratory performs Rh factor blood typing and waived hemoglobin testing. QC record review was performed for April and September of 2019 and 2020. 2. Record review showed that on 4/27/2019 the laboratory ran the Immucor "Rh Positive Cell" and "Rh Negative Cell" QC, lot number 07545 which expired on 4/26/2019. 6 patients were also tested that day; and 3. The laboratory ran expired HemoCue hemoglobin QC on 2 days in April 2019. Cross-refer to D1001. 4. During an interview on 7/15 /2021 at 2:00 PM, the TC confirmed that QC was run using controls which had exceeded their expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the written procedure and interview with the technical consultant (TC), the laboratory did not establish an Individualized Quality Control Plan (IQCP) for performing serum HCG testing. Findings: 1. The laboratory did not establish IQCP for performing serum HCG testing. 2. The laboratory did not perform quality control procedures with a positive and negative external control 3. The laboratory did not perform an IQCP that included a risk assessment, quality control plan, and a quality assessment plan. 4. The TC stated that they may run a serum HCG once a year. When performed they run a external positive and negative control. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; 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 review of competency procedures , educational requirements for performing moderately complex testing , and interview with the technical consultant (TC), the TC did not ensure all testing persons (TP) education requirements for performing red cell antigen and serum HCG testing. Findings: 1. Four out of the five TP performing moderate complex patent testing had a diploma available on the day of the survey. 2. The TP that did not have a diploma had competency procedures performed by TC during the year 2017 and 2018. 3. On the day of the survey the TC stated that the TP would get the diploma and forward. As of the time of this report the diploma has not been received. -- 2 of 2 --