Valley Day And Night Clinic

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts' (AAB) proficiency testing records from 2022, review of the laboratory's policies, and staff interview, it was revealed the laboratory failed to test proficiency samples the same number of times as patient samples. The findings include: 1. A review of the laboratory's American Association of Bioanalysts' (AAB) proficiency testing records from 2022 (Q1, Q2, and Q3) revealed proficiency testing samples were tested in duplicate for each event. 2. A review of the laboratory's policies revealed the laboratory would repeat testing on any sample which had flagged results. 3. The following proficiency testing results did not have flagged results and therefore, should not have been tested in duplicate: a) Q1 sample: 33333 sample: 555 b) Q3 sample: 131313 4. An interview with the technical consultant on 01/02/2023 at 1350 hours in the conference room - after her review of the records- confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 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 -- 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 a random review of patient test reports from 2021 and 2022, and staff interview, it was revealed the laboratory failed to include the interpretation identifying results as panic values on 6 of 6 reports. The findings include: 1. A sampling of patient test records from 2021 and 2022 revealed the following 6 of 6 records with panic values: date: 10/25/2021 Patient ID: 517972 HGB: 22.0 HCT: 66.3 date: 11/15 /2021 Patient ID: 338582 HGB: 23.4 HCT: 68.1 PLT: 43 date: 03/02/2022 Patient ID: 209862 HGB: 23.0 HCT: 66 date: 04/06/2022 Patient ID: 534079 HGB: 18.6 HCT: 55.2 date: 05/18/2022 Patient ID: 428228 HGB: 5.0 HCT: 44.0 date: 07/06/2022 Patient ID: 464177 HCT: 56.9 2. A review of the patient test results for the identified specimens revealed the values listed were not identified as "panic" on 6 of 6 report. 3. An interview with the technical consultant on 01/02/2023 at 1535 hours in the conference room - after her review of the records- confirmed the findings. KEY WBC - white blood cell HGB - hemoglobin HCT - hematocrit PLT - platelet D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, a random review of patient test records from 2021 and 2022, and staff interview, it was revealed the laboratory failed to have documentation of the notification of 6 of 8 panic values. The findings include: 1. A review of the laboratory's policy titled "CBC Flags and Panic Values" revealed: "Notify the Provider immediately, document who was notified, date and time that person was notified and the MA's initials." 2. A review of the laboratory's policy titled "Panic Values" revealed the laboratory had the following defined ranges for panic values: WBC - under 2 or over 20 HGB - under 7.5 or over 18 HCT - under 25 or over 55 PLT - under 50 or over 800 3. A sampling of patient test records from 2021 and 2022 revealed the following 6 of 8 records with panic values where the laboratory failed to have documentation of the notification of the provider: date: 10/25/2021 Patient ID: 517972 HGB: 22.0 HCT: 66.3 date: 11/15/2021 Patient ID: 338582 HGB: 23.4 HCT: 68.1 PLT: 43 date: 03/02/2022 Patient ID: 209862 HGB: 23.0 HCT: 66 date: 04/06/2022 Patient ID: 534079 HGB: 18.6 HCT: 55.2 date: 05/18/2022 Patient ID: 428228 HGB: 5.0 HCT: 44.0 date: 07/06/2022 Patient ID: 464177 HCT: 56.9 4. The laboratory was asked to provide documentation of the notification of the panic values. No documentation was provided. 5. An interview with the technical consultant on 01/02/2023 at 1535 hours in the conference room - after her review of the records- confirmed the findings. KEY WBC - white blood cell HGB - hemoglobin HCT - hematocrit PLT - platelet -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 direct observation, review of laboratory's procedure manual, American Association of Bioanalysts (AAB) General Instructions, AAB proficiency testing (PT) records, and in interview with staff, the laboratory failed to attest to the routine integration of proficiency samples into the patient workload for hematology PT samples in 2017 for 1 of 3 events (Q-3), 2018 for 2 of 3 events (Q-2, Q-3) and 2019 for 2 of 2 events (Q-1, Q-2). Findings: 1. Review of AAB GENERAL INTRUCTIONS revealed the following: "REPORTING RESULTS ... 7. Be sure to keep the attestation statements on the program instructions. We do not require these statements for grading. The attestation statements must be signed for each analyte by the analyst performing the procedure and kept in your files for inspection purposes ..." 2. Review of proficiency testing records from 2017, 2018 and 2019 all testing persons (TP) performing PT failed to sign the attestation forms for the following events: 2017 Q-3: PT was performed by 2 TP and the attestation form was only signed by 1 TP 2018 Q-2: PT was performed by 5 TP and the attestation form was only signed by 1 TP 2018 Q-3: PT was performed by 3 TP and the attestation form was only signed by 1 TP 2019 Q-1: PT was performed by 5 TP and the attestation form was only signed by 1 TP 2019 Q-2: PT was performed by 5 TP and the attestation form was only signed by 1 TP 3. During an interview on 07/16/2019 at 3:00 pm, the technical consultant stated that the PT attestation forms are signed electronically, and the electronic version only allows for one signature. She stated that the laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- practice to keep track of which TP performed PT was that all TP sign the instrument printouts for the PT that was performed by them. This confirmed the laboratory failed to ensure all attestation statements were signed by all TP. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of CMS 155 report, American Association of Bioanalysts (AAB) proficiency testing (PT) records and confirmed in staff interview, the laboratory failed to all retain hematology proficiency testing records for 2 of 3 testing events in 2018 (Q-2, Q-3) and 2 of 2 events in 2019 (Q-1, Q-2). Findings: 1. Review of CMS 155 report revealed the laboratory participated in hematology 2018 (Q-2, Q-3) and 2019 (Q-1, Q-2). The laboratory failed to maintain a copy of the following records: AAB report forms used to document PT results 2. During an interview on 07/16/2019 at 2: 29 pm, the technical consultant stated that she did not know where the AAB report forms were located and that the staff "probably threw them away," confirming the above findings. 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 Centers for Medicare and Medicaid Services (CMS) 155 reports, American Association of Bioanalysts (AAB) proficiency testing (PT) records, and confirmed in interview, the laboratory failed to attain a score of at least 80 percent for the red blood cell (RBC), hematocrit (HCT), and platelets hematology analytes for 1 of 3 proficiency testing events in 2017 (2017 3rd Event). Findings included: 1. Review of CMS 155 report for PT 2017 (third event) revealed the following unsatisfactory scores: RBC 2019 3rd Event 0% HCT 2019 3rd Event 0% Platelets 2019 3rd Event 60% The laboratory failed to attain a score of at least 80% for RBC, HCT and platelet analytes. 2. Review of AAB report for PT 2017 (third event) revealed the following unsatisfactory scores: RBC 2019 3rd Event 0% HCT 2019 3rd Event 0% Platelets 2019 3rd Event 60% 3. During an interview on 07/16/2019 at 2:54 pm, the technical consultant confirmed the laboratory failed to attain a score of at least 80% for the above mentioned analytes. -- 2 of 6 -- D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare and Medicaid Services (CMS) 155 reports, American Association of Bioanalysts (AAB) proficiency testing (PT) records, and confirmed in interview, the laboratory failed to attain a score of at least 80 percent for each testing event in the specialty of hematology. Findings: 1. Review of CMS 155 report for PT 2017 (third event) revealed the laboratory received an overall score of 60% for the specialty of hematology. This constitutes unsatisfactory performance in hematology for the third testing event of 2017. 2. Review of AAB PT records revealed PT 2017 (third event) the laboratory received an overall score of 60% for the specialty of hematology. This constitutes unsatisfactory performance in hematology for the third testing event of 2017. 3. During an interview on 07/16/2019 at 2:54 pm, the technical consultant confirmed the laboratory failed to attain a score of at least 80% for the specialty of hematology third testing event in 2017. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policy, and confirmed in interview of facility personnel, the laboratory failed to follow its own policy for specimen labeling. The findings were: 1. Surveyor observation 1: made on July 16, 2019 at 16:30 hours in the laboratory revealed a patient's urine specimen in process on the analyzer. The specimen was not labeled with any identifying information. Further observations revealed a CBC (complete blood count) collected in a purple top with only the patient's first and last name. 2. Surveyor observation 2: during a tour of the laboratory on 07/16/2019 at 1:07 pm, the surveyor observed an unlabeled urine specimen in the refrigerator used for the storage of vaccinations. The laboratory failed to follow its own written policy for labeling specimens using unique patient identifiers. 3. Review of the laboratory's policies revealed a policy approved and signed by the laboratory director on November 20, 2013 that stated, "Specimen Identification: Each specimen must have unique identifiers such as name and date of birth. These identifiers will be used throughout the testing process so that results can be confidently used in patient care. This can be done by using LIS labels for tubes." 4. The laboratory did not follow its own policy for specimen labeling 5. The above findings were confirmed in interview with the technical consultant on July 16, 2019 at 16:45 hours in the laboratory when she told the testing person that all specimens must be labeled even if they are for worker's compensation. -- 3 of 6 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)