Westcare Medical Center Apmc

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 13, 2022 at Westcare Medical Center, APMC, CLIA ID # 19D0693739. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory's records, manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Review of the laboratory's test menu revealed the laboratory utilizes the Quidel Quickvue for SARS COV-2 testing. 2. Review of the manufacturer's instructions revealed "Authorized laboratories * using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. Review of the laboratory's records revealed the laboratory did not have a Fact Sheet for the Quidel Quickvue SARS COV-2. 4. In interview on May 13, 2022 at 9:40 am the Technical Consultant 1 confirmed the laboratory does not provide "fact sheets" to patients for the Quidel Quickvue SARS COV-2 tests. 5. Review of the laboratory's test menu revealed the laboratory performs 1,429 Quidel Quickvue SARS COV-2 tests annually. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 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 -- 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). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of test logs, and interview with personnel, the laboratory failed to report 2,104 SARS COV-2 results to the state as required. Findings: 1. In interview on May 13, 2022 at 9:11 am, Technical Consultant 1 stated the laboratory utilized the BD Veritor system for SARS COV-2 testing January 27, 2021 through August 12, 2021. Technical Consultant 1 further stated the laboratory stopped utilizing the BD Veritor system and switched to Quidel Quickvue test kits for SARS COV-2 testing on September 17, 2021. 2. Observation by surveyor during the laboratory tour on May 13, 2022 at 10:33 am revealed the laboratory utilized Quidel Quickvue antigen SARS COV-2 test kits. 3. In interview on May 13, 2022 at 9:49 am, Technical Consultant 1 stated the laboratory tried to set up reporting in 2021, but the laboratory's system did not have the ability to automatically submit results. Technical Consultant 1 further stated the laboratory did not report any SARS COV-2 results to the state. 4. Review of the laboratory's SARS COV-2 test logs revealed the laboratory tested 836 patients January 18, 2021 through August 26, 2021 utilizing the BD Veritor system and 1,268 patients September 17, 2021 through May 12, 2022 utilizing the Quickvue test kits. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to establish written policies for reporting SARS COV- 2 results. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have written procedures for reporting SARS COV-2 results, to include, but not limited to who is responsible, and frequency of reporting. 2. In interview on May 13, 2022 at 9:49 am, Technical Consultant 1 confirmed the laboratory did not have a written policy for reporting positive and negative SARS COV-2 results to the state. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, -- 2 of 4 -- either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's instructions, patient final test reports, test menu, and interview with personnel, the laboratory failed to include the Food and Drug Administration (FDA) Emergency Use Authorization statement on SARS COV-2 patient final reports. Findings: 1. Observation by surveyor during the laboratory tour on May 13, 2022 10:33 am revealed the laboratory utilizes the Quidel Quickvue SARS COV-2. 2. Review of the manufacturer's instructions revealed "This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories." 3. Review of the following random selection of patient final reports for SARS COV-2 revealed the laboratory did not include the identified Emergency Use Authorization statement on patient final reports: Patient 392457 Patient 392430 Patient 403163 4. In interview on May 13, 2022 at 12:12 pm, Technical Consultant 1 confirmed the laboratory's patient final reports for SARS COV-2 did not include the identified statement. 5. Review of the laboratory's test menu revealed the laboratory performs 1,429 SARS COV-2 tests annually. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure patient final reports included required pertinent information. Refer to D5805. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5401. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Special focus survey was performed at Westcare Medical Center, APMC-CLIA ID 19D0693739 on May 13, 2022. Westcare Medical Center, APMC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility Administration 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 review of the laboratory's records, manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Review of the laboratory's test menu revealed the laboratory utilizes the Quidel Quickvue for SARS COV-2 testing. 2. Review of the manufacturer's instructions revealed "Authorized laboratories * using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. Review of the laboratory's records revealed the laboratory did not have a Fact Sheet for the Quidel Quickvue SARS COV-2. 4. In interview on May 13, 2022 at 9:40 am the Technical Consultant 1 confirmed the laboratory does not provide "fact sheets" to patients for the Quidel Quickvue SARS COV-2 tests. 5. Review of the laboratory's test menu revealed the laboratory performs 1,429 Quidel Quickvue SARS COV-2 tests annually. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 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 -- 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). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of test logs, and interview with personnel, the laboratory failed to report 2,104 SARS COV-2 results to the state as required. Findings: 1. In interview on May 13, 2022 at 9:11 am, Technical Consultant 1 stated the laboratory utilized the BD Veritor system for SARS COV-2 testing January 27, 2021 through August 12, 2021. Technical Consultant 1 further stated the laboratory stopped utilizing the BD Veritor system and switched to Quidel Quickvue test kits for SARS COV-2 testing on September 17, 2021. 2. Observation by surveyor during the laboratory tour on May 13, 2022 at 10:33 am revealed the laboratory utilized Quidel Quickvue antigen SARS COV-2 test kits. 3. In interview on May 13, 2022 at 9:49 am, Technical Consultant 1 stated the laboratory tried to set up reporting in 2021, but the laboratory's system did not have the ability to automatically submit results. Technical Consultant 1 further stated the laboratory did not report any SARS COV-2 results to the state. 4. Review of the laboratory's SARS COV-2 test logs revealed the laboratory tested 836 patients January 18, 2021 through August 26, 2021 utilizing the BD Veritor system and 1,268 patients September 17, 2021 through May 12, 2022 utilizing the Quickvue test kits. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to establish written policies for reporting SARS COV- 2 results. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not have written procedures for reporting SARS COV-2 results, to include, but not limited to who is responsible, and frequency of reporting. 2. In interview on May 13, 2022 at 9:49 am, Technical Consultant 1 confirmed the laboratory did not have a written policy for reporting positive and negative SARS COV-2 results to the state. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, -- 2 of 4 -- either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's instructions, patient final test reports, test menu, and interview with personnel, the laboratory failed to include the Food and Drug Administration (FDA) Emergency Use Authorization statement on SARS COV-2 patient final reports. Findings: 1. Observation by surveyor during the laboratory tour on May 13, 2022 10:33 am revealed the laboratory utilizes the Quidel Quickvue SARS COV-2. 2. Review of the manufacturer's instructions revealed "This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories." 3. Review of the following random selection of patient final reports for SARS COV-2 revealed the laboratory did not include the identified Emergency Use Authorization statement on patient final reports: Patient 392457 Patient 392430 Patient 403163 4. In interview on May 13, 2022 at 12:12 pm, Technical Consultant 1 confirmed the laboratory's patient final reports for SARS COV-2 did not include the identified statement. 5. Review of the laboratory's test menu revealed the laboratory performs 1,429 SARS COV-2 tests annually. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure patient final reports included required pertinent information. Refer to D5805. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5401. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on March 12, 2020 at Westcare Medical Center, CLIA ID # 19D0693739. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation, record review, and interview with personnel, the laboratory failed to follow the manufacturer's requirements for the Ictotest. Findings: 1. Observation by surveyor during laboratory tour on March 12, 2020 revealed the laboratory utilizes Siemens Ictotest Reagent tablets for bilirubin testing. Surveyor observed Ictotest Reagent tablets, lot # 284076A, in drawer located in the laboratory. 2. Review of the manufacturer's package insert under "Quality Control" section revealed "For best results performance should be confirmed by testing known negative and positive specimens or controls whenever a new bottle is first opened." 3. In interview on March 12, 2020 at 11:30 am, the Technical Consultant stated no quality control is done. The Technical Consultant further stated when a new lot of tablets are received it is put into use without testing with quality controls. 4. In further interview on March 12, 2020 the Technical Consultant stated she was unable to determine at the time of the survey how many patients had the Ictotest performed . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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: *** Repeat deficiency from previous survey conducted on March 21, 2018. *** Based on record review and interview with personnel, the laboratory failed to follow their written policies and procedures to address competency for the Technical Consultant. Findings: 1. Review of the laboratory's "Competency Assessment" policy revealed "Testing personnel and technical consultant assessment must be performed annually with six required procedures in their competency assessment, pre-analytic, analytic, post analytic which includes proficiency testing and quality control program. 2. Review of personnel records for the Technical Consultant revealed no documentation of competency assessments for her Technical Consultant duties for 2018 and 2019. 3. In interview on March 12, 2020 at 10:52 am, the Technical Consultant stated the Laboratory Director did not perform an annual competency assessment for her duties as Technical Consultant. 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 observation, record review, and interview with personnel, the laboratory failed to monitor the temperature where supplies are stored. Findings: 1. Observation by surveyor during laboratory tour on March 12, 2020 revealed the following items stored in a storage room without monitoring the temperature: a) BD Vacutainer K2EDTA blood collection tubes, Lot 9280900, Quantity: two (2) boxes b) BD Vacutainer K2EDTA blood collection tubes, Lot 9260556, Quantity: three (3) boxes c) Vacuette blood collection tubes, Lot B191139U, Quantity: one (1) box 2. Review of the manufacturer's storage requirements revealed the following: a) BD Vacutainer blood collection tubes, storage requirement 4-25 degrees Celsius b) Vacuette blood collection tubes, storage requirement 4-25 degrees Celsius 3. In interview on March 12, 2020 at 9:20 am, the Technical Consultant stated the laboratory does not monitor the temperature of the storage room where the identified items are stored. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the laboratory failed to label stain in a secondary container with identity, expiration date, and storage requirements. Findings: 1. Observation by surveyor during laboratory tour on March 12, 2020 revealed a stain in a secondary container without identity, storage requirement, and expiration date included. 2. In interview on March 12, 2020, the Technical Consultant stated the filtered Wright stain (Wrights One Step Stain, Lot # 8681-00) was in the identified container. The Technical Consultant confirmed the container was unlabeled. 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 and interview with personnel, the laboratory failed to ensure laboratory supplies had not exceeded their expiration date. Findings: 1. Observation by surveyors during the laboratory tour on March 12, 2020 revealed the following expired blood collection tubes: a) BD Vacutainer SST, Lot # 9058692, Expiration date: 2020-02-29, Quantity: eleven (11) tubes b) BD Vacutainer SST, Lot # 9030868, Expiration date: 2020-01-31, Quantity: four (4) tubes 2. In interview on March 12, 2020, Testing Personnel 3 confirmed the identified items were expired. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel were performing test methods as required. Findings: 1. The laboratory failed to monitor the temperature where supplies are stored. Refer to D5413. 2. The laboratory failed to label stain in a secondary container with identity, expiration date, and storage requirements. Refer to D5415. 3. The laboratory failed to ensure laboratory supplies had not exceeded their expiration date. Refer to D5417. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 3 of 4 -- 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: *** Repeat deficiency from previous survey conducted on March 21, 2018. *** Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency. Refer to D5209. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on March 21, 2018 at Westcare Medical Center, APMC-CLIA ID # 19D0693739. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Technical Consultant were complete. Findings: 1. Review of the laboratory's CMS-20r form (Laboratory Personnel Report revealed Personnel 2 serves as the Technical Consultant. 2. Review of the laboratory's "Competency Assessment Program" policy revealed it did not include competency assessment of Technical Consultant. 3. Review of personnel records revealed competency assessment for the duties of Technical Consultant were not performed. 4. In interview on March 21, 2018 at 10:33 am, Personnel 2 stated the laboratory did not have a policy for competency assessment for the duties of Technical Consultant. Personnel 2 further stated competency assessment for her duties as Technical Consultant were not performed. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D5209. -- 2 of 2 --