Peninsula Medical Center For Women

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Peninsula Medical Center for Women on June 5, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is 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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, and an interview, the laboratory failed to rotate immunohematology PT among personnel performing patient Rh Factor type testing for four (4) of five (5) events reviewed (timeframe: September 2022 to the date of the inspection on June 5, 2024). Findings include: 1. Review of the CMS 209 revealed three TP identified as responsible for moderate complexity immunohematology Rh Factor type testing during the timeframe of the inspection (9/14/22 to 6/5/24). 2. Review of the laboratory's American Proficiency Institute (API) PT documentation, a total of 5 events (2022 Event 3, 2023 Events 1-3, 2024 Event 1), revealed that Testing Personnel A (TP A) signed attestation statements for the following Blood Bank ABO/Rh module events: API 2022 Event 3; API 2023 Event 1; API 2023 Event 2; API 2023 Event 3; TP A performed 4 of 5 events reviewed. (See Personnel Code Sheet) 3. An exit interview with the facility director on 6/5/24 at 12:30 PM confirmed the above findings. 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 D0000 An announced CLIA recertification survey was conducted at Peninsula Medical Center for Women on September 13, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes one Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. 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 a review of procedures, manufacturer's user guide/package inserts, daily temperature/environment logs, maintenance logs, tour, patient test logs, quality conrol (QC) records, lack of documentation, and an interview, the laboratory failed to: 1. monitor room and refrigerator temperatures to ensure manufacturer's requirements were followed for blood type grouping reagent and QC materials utilized for Anti-D Rh antigen patient testing for eight (8) days while reporting seventeen (17) patient results during twenty-one (21) months reviewed (January 2021 to September 13, 2022). Cross Reference- D5413; 2. document annual revolutions per minute verification for one Drucker Company centrifuge in use for blood typing procedures in calendar year 2021. Cross Reference- D5435; 3. document Anti-D Rh antigen QC on 8 days while reporting 17 patient results during the 21 months reviewed. Cross Reference- D5449. 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 -- 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 review of procedures, manufacturer's user guide/package inserts, daily temperature/environment logs, lack of documentation, and an interview, the laboratory failed to monitor daily room/refrigerator temperatures to ensure manufacturer's requirements were followed for blood type grouping reagent and quality control (QC) materials utilized for Anti-D Rh antigen patient testing for eight (8) days while reporting seventeen (17) patient results during the twenty-one (21) months reviewed (timeframe: January 2021 to September 13, 2022). Findings include: 1. Review of the facility's laboratory procedure manual revealed a Quality Assurance protocol (title: Temperature Log) that outlined daily monitoring of environmental conditions that include laboratory room and refrigerator temperatures. The policy stated: "The temperature of the refrigerator and the laboratory will be checked any day that testing is performed. The refrigerator must be 2-8 degrees Celsius. The room temperature must be 20-24 degrees Celsius." 2. Review of manufacturer's package insert guidelines revealed the following requirements: ALBAclone Blood Grouping Reagent Anti-D Blend - "Store at 2-8 C"; ALBAcheck-BGS Monoclonal Control - "Storage conditions: the reagent should be stored at 2-8 C."; Search-Cyte Reagent Blood Cells - "Store at 2-8 C. Do not freeze.", "Saline Tube Procedure: Incubate at room temperature (20-25 C) for 15-30 minutes." 3. Review of the available temperature log records from January 2021 to 9/13/22 revealed no laboratory room temperature or refrigerator temperature monitoring on the following 8 days of patient testing: 1/22/21, 3/09/21, 3/10/21, 4/28/21, 1/14/22, 3/28/22, 3/29/22, 8/03/22. The inspector requested to review documentation of the temperature monitoring according to policy and manufacturer's specifications. No records were available for review. 4. An exit interview with the facility manager and primary testing personnel on 9/13/22 at approximately 12:30 PM confirmed the above findings. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on a review of the procedure manual, package inserts, tour, maintenance logs, lack of documentation, and interviews, the laboratory failed to document annual revolutions per minute (RPM) verification for one Drucker Company centrifuge in use for Anti-D Rh blood typing procedures in calendar year 2021 (review timeframe: January 2021 to September 13, 2022). Findings include: 1. Review of the laboratory procedure manual revealed the following policy protocol: Rh Testing Policy - "Centrifuge test tubes at 3400 RPM setting for 10 seconds". 2. Review of ALBAclone Anti-D blood typing reagent package insert revealed manufacturer's instructions: "Centrifuge at 3400 RPM for 10 seconds". 3. During a tour with the facility's office manager on 9/13/22 at approximately 11:30 AM, the inspector noted one Drucker Company 614B centrifuge (serial number 161007-294) in use for Anti-D Rh blood typing procedures with a Merco Biomedical maintenance sticker dated March 2022 without RPM indication. The inspector inquired regarding the laboratory policy for RPM checks. The facility manager stated on 9/13/22 at approximately 11:40 AM, "Our quality assurance policy is to have the biomed company verify the lab's centrifuge speed for the Rh test at least once per year when they come in to inspect all of our surgical equipment. We had to replace a centrifuge a while ago because it could not maintain the required speed." 4. Review of the laboratory's maintenance documentation revealed one record of RPM verification by a Merco Biomedical field service representative completed on 3/11/22 ("614B serial number 161007-294 Tac Reading 3300"). The inspector requested to review an annual centrifuge RPM check recorded for calendar year 2021. No additional records were available for review. 5. An exit interview with the facility manager and primary testing personnel on 9/13/22 at approximately 12:30 PM confirmed the above findings. 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 a tour, review of procedure manual, patient test logs, quality control (QC) records, lack of documentation, and an interview, the laboratory failed to document Anti-D Rh antigen QC on eight (8) days while reporting seventeen (17) patient results during the twenty-one (21) months reviewed (timeframe: January 2021 to September 13, 2022). Findings include: 1. During a tour of the facility's laboratory testing area, the inspector noted moderate complexity ALBAclone Anti-D Blend Tube RhD blood group test reagent and ALBAcheck-BGS RhD QC reagent stored and in use for RhD antigen detection. 2. Review of the laboratory's procedure manual revealed the following three policies outlining QC protocols: Rh Testing Procedure: "Rh controls are to be run each day that testing is performed."'; Quality Control Procedure: "Quality controls for Anti-D will be conducted any day that lab services are rendered. The QC results along with the lot number and expiration date of the control will be logged."; Anti-D Blood Group Quality Assurance Procedure: "Quality control of reagents is essential and a positive and negative will be performed with each RhD test". 3. Review of patient laboratory test and QC logs from January 2021 to the date of the survey on 9/13/22 revealed the following 8 days with no QC documentation and number of patients tested per date: 1/22/21 - one 3/09/21 - two 3/10/21 - three 4/28/21 -- 3 of 4 -- - one 1/14/22 - one 3/28/22 - five 3/29/22 - three 8/03/22 - one A total of 8 days noted with no QC documentation while testing/resulting 17 patients' Anti-D Rh blood typing. The inspector requested to review the QC documentation on the dates of patient testing outlined above. No additional QC documentation was available for review. 4. An exit interview with the facility manager and primary testing personnel on 9/13/22 at approximately 12:30 PM confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Peninsula Medical Center for Women on November 10, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 11/5/2020, virtual record review conducted on 11/9/2020, and exit interview on 11/11/20. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a review of the CASPER Survey Summary (Report 0096D), proficiency testing (PT) documentation, Centers for Medicare and Medicaid Services (CMS) 116 form, PT enrollment documents, and interviews, the laboratory failed to release proficiency testing results to the regulatory agencies of Centers for Medicare and Medicaid Services (CMS) and the Virginia Department of Health (VDH) for five (5) of 5 PT events reviewed. Findings include: 1. During pre-survey preparation, the inspector reviewed a Survey Summary (Report 0096D) in the CASPER program database for Peninsula Medical Center for Women, 49D2038943. Review of the Summary Report revealed no PT scores for calendar year 2019 and year to date 2020. 2. Review of the laboratory's American Proficiency Institute (API) immunohematology PT documentation (2019 Events 1-3, 2020 Events 1-2; a total of 5 events) during the facility's record review, on 11/9/20, revealed that API recorded the facility's CLIA ID as 49D0226811. The inspector inquired of the laboratory director (LD) regarding documentation of contact/enrollment with the API PT 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 -- program and the discrepant CLIA ID on reporting. The LD stated on 11/9/20, at approximately 12 Noon, "I do not have an explanation but will need to look into this matter". 3. Review of the laboratory's CMS 116 form confirmed that the LD acknowledged that Peninsula Medical Center for Women CLIA number as 49D2038943 and physical address 10758 A Jefferson Avenue Newport News, Virginia 23601. 4. The inspector requested to review the laboratory's API enrollment forms for calendar year 2019 and 2020. Review of the API order enrollment confirmations revealed that the laboratory provided a CLIA number as 49D0226811 for Peninsula Medical Center for Women with shipping instructions as 10758 A Jefferson Avenue Newport News Virginia 23601. The LD stated on 11/11/20 at approximately 2:00 PM, "Yes, the proficiency test order for Peninsula and it does have our Richmond office's CLIA number in error". 5. In an exit interview with the LD, on 11/11/20 at approximately 2:30 PM, the above findings were confirmed. -- 2 of 2 --