Bayview Medical Center

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency test desk review was conducted for Bayview Medical Center-Nowcare II on July 7-8, 2022 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, including Condition under 42 CFR part 493 CLIA Regulations - D2016 - 42 CFR. 493.803 Condition: Successful Participation). 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 an off-site desk review of the laboratory's American Proficiency Institute proficiency testing (PT) records and interviews, the laboratory failed to attain a score 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 -- of at least eighty percent of acceptable responses for glucose and human chorionic gonadatropin (HCG) in two consecutive Chemistry testing events resulting in unsuccessful PT performance (reviewed: 2022 First and Second Event). See D2097. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of proficiency testing (PT) results and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable analyte responses for Glucose (GLU) and human chorionic gonadatropin (HCG) on two (2) consecutive chemistry testing events reviewed for calendar year 2022 (Events 1-2). Findings include: 1. Review of the laboratory's American Proficiency Institute (API) Chemistry module results, revealed analyte scores of less than 80% for the following consecutive events: API Chemistry Endocrinology 2022 Event 1- HCG 0% (with API comment scored zero due to failure to participate); API Chemistry Endocrinology 2022 Event 2- HCG 0% (with API comment scored zero due to failure to participate); API Chemistry Routine 2022 Event 1- Hemocue Glu 0% (with API comment scored zero due to failure to participate); API Chemistry Routine 2022 Event 2- Hemocue Glu 0% (with API comment scored zero due to failure to participate). 2. Interviews with the laboratory's clinical coordinator by email on 07/07 /22 at approximately 10:00 AM, and additional telephone interview on 07/08/22 at 4: 30 PM, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for Bayview Medical Center on June 21, 2022 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: 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 relative humidity percent (%) and refrigerator temperatures to ensure manufacturer's operating and storage requirements were followed for the Abbott Emerald analyzer and hematology quality control (QC) materials utilized for Complete Blood Count (CBC) patient testing for twenty-eight (28) months reviewed (timeframe: February 2020 to the date of the inspection on June 21, 2022). Findings include: 1. Review of the laboratory's procedures revealed Quality Assurance protocols that outlined daily monitoring of environmental conditions that included laboratory room temperature/humidity and refrigerator/freezer temperatures. 2. Review of the Abbott manufacturer's guidelines revealed the following requirements: Emerald analyzer user guide - "Environmental Specifications: relative humidity range is 80% maximum"; Cell-Dyn QC package insert - "Stable through 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 -- expiration date when stored 2-8 C, opened stability is eight consecutive days after open stored at 2-8 C". 3. Review of the available laboratory records for calendar year 2020, 2021, and year to date 2022 revealed no record of laboratory room temperature /humidity or refrigerator temperature monitoring. The inspector requested to review documentation of the monitoring to manufacturer's specifications. No records were available for review. 4. An exit interview with the clinical consultant on 6/21/22 at approximately 4:00 PM confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, lack of documentation, and an interview, the technical consultant (TC) failed to document hematology competency assessment for two (2) of 2 testing personnel (TP) in calendar years 2020 and 2021. Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) identified TP A and TP B as responsible for performing hematology patient testing during calendar years 2020 and 2021. The LD also serves as TC. *See Personnel Code Sheet. 2. Review of personnel records revealed no Abbott Emerald hematology competency assessment for the 2 TP outlined above in calendar years 2020 and 2021. The inspector requested to review competency assessment documentation for both years. The clinical coordinator stated at approximately 3:30 PM: "We are having trouble finding the competency assessments to show you". No records were made available for review. 3. An exit interview with the clinical consultant on 6/21/22 at approximately 4:00 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency test desk review was conducted for Bayview Medical Center-Nowcare II on January 6-7, 2021 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: 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 an off-site desk review of the laboratory's American Proficiency Institute proficiency testing (PT) records and interviews, the laboratory failed to attain a score of at least eighty percent of acceptable responses for White Blood Cell Differential 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 -- (Granulocytes, Lymphocytes, Monocytes) in two of three hematology testing events reviewed, resulting in an unsuccessful PT performance (reviewed: 2020 Events 1-3). See D2130. 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 an off-site desk review of proficiency testing (PT) records (2020 Events 1-3) and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for White Blood Cell Differential Identification (WBC Diff) in the two (2) of three (3) hematology testing events reviewed, resulting in an unsuccessful PT performance. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT records revealed WBC Diff scores of less than 80% for the following 2 events: API 2020 Hematology Event 1 - WBC Diff = 0%; Score for all five (5) challenges HEM #01- HEM -#05: Granulocytes = 0%, Lymphocytes = 0%, Monocytes = 0%; API report noted "results unsatisfactory performance"; API 2020 Hematology Event 3 - WBC Diff = 0 %; Score for all five (5) challenges HEM #11- HEM -#15: Granulocytes = 0%, Lymphocytes = 0%, Monocytes = 0%; API report noted "laboratory failed to participate"; resulting in an unsuccessful PT performance. 2. In an email correspondence interview with the facility's clinical coordinator on 1/6/21 at approximately 11:00 AM, and a telephone interview with the technical consultant on 1/7/21 at approximately 12:30 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bayview Medical Center- Nowcare II on January 8, 2020 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: D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of 2018 and 2019 proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to document remedial /

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Bayview Medical Center on March 20, 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: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report (CLIA) (Form CMS-209), procedure manual, and interviews, the laboratory failed to establish written procedures for competency assessment of the Potassium Hydroxide (KOH) and Vaginal Wet Preparations (Wet Prep) microscopic examinations. Findings include: 1. Review of the Form CMS-209 revealed that there are two (2) testing personnel (TP) performing KOH and Wet Prep microscopic examinations. See attached list. 2. Review of the laboratory's procedure manual revealed no written competency assessment procedure for those individuals performing the above-mentioned testing. 3. An interview with the office manager and primary TP at approximately 1:00 PM confirmed that the laboratory did not have competency assessment procedures for the KOH and Wet Prep microscopic examinations. 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. 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 -- This STANDARD is not met as evidenced by: Based on the review of the policy and procedure manual, proficiency testing records and an interview with the primary testing personnel (TP), the laboratory failed to verify the accuracy of the vaginal wet preparations (Wet Prep) microscopic examinations twice a year in 2017. Findings include: 1. Review of the policy and procedure manual revealed that the laboratory performs Wet Prep microscopic examinations. 2. Review of the American Proficiency Institute (API) 2017 records for Wet Prep revealed the following scores: 2017 Event 1- 0%, 2017 Event 3- 0%. An interview with the primary TP at approximately 10:35 AM revealed that the laboratory utilizes API proficiency testing to verify the accuracy of the Wet Prep examinations twice a year. The inspector requested to review additional accuracy checks for Wet Prep due to the failures received from API. There was no additional documentation available for review. 3. An interview with the office manager and primary TP at approximately 1:00 PM confirmed that the laboratory failed to verify the accuracy of the Wet Prep microscopic examinations twice a year in 2017. 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 package insert (PI), temperature logs and interviews, the laboratory failed to follow the manufacturer's storage requirements for Hematology quality control materials for seventy-seven (77) of two-hundred and seventy-three (273) days reviewed from June 1, 2016 through June 30, 2017. Findings include: 1. Review of the Cell Dyn 18 Plus Control PI for storage requirements revealed that the quality control materials are to be stored at 2-10 degrees Celsius. 2. Review of the refrigerator temperature logs revealed the temperatures colder than 2 degrees Celsius for the following number of days: October 2016- 9 days, November 2016- 7 days, December 2016- 21 days, January 2017- 8 days, February 2017- 9 days, March 2017- 9 days, April 2017- 5 days, May 2017- 4 days, June 2017- 5 days, A total of 77 days. 3. An interview with the office manager and primary testing personnel at approximately 1:00 PM confirmed that the laboratory failed to follow the manufacturer's storage requirements for the Hematology quality control materials for the months and number of days listed above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a tour of the laboratory, manufacturer's package insert (PI), maintenance records, an interviews, the laboratory failed to follow the manufacturer maintenance protocols for one (1) of one (1) thermometer used to monitor the refrigerator temperatures from October 1, 2016 and up to the date of survey on March 20, 2018. Findings include: 1. The tour of the laboratory revealed that the refrigerator in the laboratory contained quality control materials for the hematology analyzer. The laboratory utilizes the Fisher Scientific Min-Max Time Setup Thermometer, serial number 140632893 with calibration expiration date of 09/22/2016, to monitor the refrigerator temperatures. 2. Review of the PI for the thermometer revealed the following statement: "Calibration and Preventative Maintenance: Each digital thermometer should be sent back to the manufacturer for recalibration or replacement (whichever option is more cost effective) nearing the recalibration date printed on the recalibration sticker located on the back of the thermometer." 3. Review of the laboratory's equipment maintenance records from October 1, 2016 and up to the date of survey on March 20, 2018 revealed no calibration documentation for the thermometer (140632893) prior to 09/22/2016 or the purchase of a new thermometer with a current calibration date. The inspector also requested to review documentation of a written maintenance protocol for verifying the accuracy of the expired thermometer. The documentation was not available for review. 4. An interview with the office manager and primary testing personnel at approximately 1:00 PM confirmed that the laboratory did not follow the manufacturer maintenance protocols for 1 thermometer used to monitor the refrigerator temperatures from October 1, 2016 and up to the date of survey on March 20, 2018. 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 review of the package insert (PI), patient data report, and interviews, the laboratory failed to perform external quality control materials for the serum Human Chorionic Gonadotropin (HCG) tests each day of patient testing in 2017 for six (6) of the six (6) patients reported. Findings include: 1. Review of the Consult HCG serum /urine combo test kit PI revealed that the use of serum samples for this test kit is categorized moderate complexity testing. The review of the PI also revealed that the manufacturer recommends that external quality control materials be run with each new kit lot number and follow local, state, and/or federal regulations. 2. The inspector requested to review the documentation of performing the external quality control materials each day of patient testing using serum samples. The documentation was not available for review. Review of the SRS Electronic Medical Record patient data report for serum HCG tests reported in 2017 revealed the following 6 patients: Patient A- reported 01/12/2017, Patient B- reported 01/23/2017, Patient C- reported 02/03 /2017, Patient D- reported 03/22/2017, Patient E- reported 04/24/2017, Patient F- reported 05/11/2017. 3. An interview with the office manager and primary testing personnel at approximately 1:00 PM confirmed that the laboratory failed to perform -- 3 of 5 -- external quality control materials for the serum HCG tests each day of patient testing in 2017. D5785