Bernhardt Laboratories

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of annual gynecologic cytology proficiency testing (PT) program instructions, annual gynecologic cytology PT participation records and interviews with the PT Proctor, Acting General Manager and Cytology Supervisor Facility B (CLIA #10D0645099) failed to meet the specified requirements for gynecologic cytology PT examination in 2020, 2021 and 2022. Facility B referred a gynecologic cytology PT set consisting of ten slides to Facility A (CLIA #10D2144349) in 2021 and 2022 (refer to D2013). The laboratory failed to administer the annual gynecologic cytology PT as required by the PT program's instructions in 2020, 2021 and 2022 (refer to D2015). Findings include: 1. Facility B referred a gynecologic cytology PT set consisting of ten slides to Facility A by courier for analysis by Technical Supervisor C in 2021 and 2022 (refer to D2013). a. During an interview on June 21, 2022 at 9:50 AM these findings were confirmed by PT Proctor. b. During an interview on June 22, 2022 at 9:14 AM these findings were confirmed by Acting General Manager. 2. The laboratory failed to follow the PT program's instructions in 2020, 2021 and 2022 (refer to D2015). a. During an interview on June 21, 2022 at 9:50 AM these findings were confirmed by PT Proctor. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on review of PT provider instructions, annual gynecologic cytology PT participation records, interviews with the PT Proctor and Acting General Manager and review of PT policies and procedures Facility B referred a gynecologic cytology PT set consisting of 10 slides to Facility A for analysis by Technical Supervisor C in 2021 and 2022. The PT Proctor failed to sign the result form within the timeframe established by the PT program for eight of eleven result forms in 2020 and eleven of twelve result forms in 2021. The PT proctor failed to sign the result form as required by the PT program for one of two Technical Supervisors in 2022. Findings include: 1. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS which stated: -"Testing material is not allowed to travel between sites." a. During an interview on June 21, 2022 at 9:50 AM PT Proctor stated: -Facility B referred a PT set consisting of ten slides to Facility A for analysis by Technical Supervisor C in 2021 and 2022. b. During an interview on June 22, 9:14 AM these findings were confirmed by Acting General Manager. 2. The Survey Team reviewed annual gynecologic cytology PT participation records for 2021. Facility B referred a gynecologic cytology PT set consisting of 10 slides to Facility A for analysis by Technical Supervisor C in 2021. a. Technical Supervisor C tested on the 10-slide testing slideset #34459 on February 9, 2021. 3. The Survey Team reviewed annual gynecologic cytology PT participation records for 2022. Facility B referred a gynecologic cytology PT set consisting of 10 slides to Facility A for analysis by Technical Supervisor C in 2022. a. Technical Supervisor C tested on the 10-slide testing slideset #34364 on February 9, 2022. 4. During an interview on June 21, 2022 at 9:50 AM PT Proctor stated: -A 10- slide gynecologic cytology PT set was sent by Facility B to Facility A by courier for analysis by Technical Supervisor C in 2021 and 2022. -Technical Supervisor C reviewed the slides and completed the PT result form at Facility A then returned the slides and result form by courier to Facility B the following day in 2021 and 2022. - There was no proctor present during PT examination at Facility A in 2021 and 2022. - "We treat as a routine patient sample." a. During an interview on June 22, 2022 at 9: 14 AM these findings were confirmed by Acting General Manager. 5. The laboratory failed to follow procedure PROFICIENCY TESTING which stated: -"It is prohibited to accept PT from another laboratory or refer PT specimen to another laboratory." a. -- 2 of 10 -- During an interview on June 22, 2022 at 9:14 AM, the Acting General Manager confirmed that FACILITY B referred PT specimens to FACILITY A for analysis by Technical Supervisor C at FACILITY A. 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 annual gynecologic cytology PT program instructions, annual gynecologic cytology PT participation records and interviews with the PT Proctor, Acting General Manager and Cytology Supervisor the laboratory failed to administer and document the PT examination as required by the PT provider's laboratory proctor instructions in 2020, 2021 and 2022. Findings Include: 1. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS which stated: - "Monitor the test environment." a. During an interview on June 21, 2022 at 9:50 AM these findings were confirmed by PT Proctor who stated: -There was no proctor at Facility A during gynecologic cytology PT events in 2021 and 2022. 2. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS which stated: - "Observe the time and collect all test materials from the examinee after 2 hours, whether or not he or she has completed the test." a. During an interview on June 21, 2022 at 9:50 AM PT Proctor stated: -Technical Supervisor C examined the PT slides and completed the result form at Facility A then returned the materials by courier on the following day in 2021 and 2022. 3. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS which stated: -"The testing material can only be opened by a passing proctor; the director needs to notify all staff once the testing material is received by the laboratory, but only a passing proctor is allowed break the security seal and check the contents of the package." a. During an interview on June 21, 2022 at 9:50 AM these findings were confirmed by PT Proctor who stated: -Upon receipt into the laboratory PT Proctor opened the package and inspected its contents with Cytology Supervisor. -Cytology Supervisor was not a proctor. b. During an interview on June 21, 2022 at 5:05 PM these findings were confirmed by Cytology Supervisor. 4. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS which stated: -"Record the examinees stop time on the result form. Have the examinee sign in the area marked 'Examinee signature'. Sign your name by 'Proctor signature.'" a. The Survey Team reviewed annual gynecologic cytology PT result forms for 2020. PT Proctor failed to sign the result form within the timeframe established by the PT program for eight of eleven result forms in 2020. 2020 CAP -- 3 of 10 -- GYNECOLOGIC CYTOLOGY-PAP PT INDIVIDUAL RESULT FORMS include: - Kit #32740356, Slideset #34431 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 -Kit #32740357, Slideset #34430 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 -Kit #32740358, Slideset #34430 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 -Kit #32740359, Slideset #34430 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 -Kit #32740360, Slideset #34430 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 -Kit #32740361, Slideset #34423 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 -Kit #32740362, Slideset #34423 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 -Kit #32747323, Slideset #34423 Ten slides Examinee signature date: 10/05/2020 PT Proctor signature date: 10/07/2020 b. The Survey Team reviewed annual gynecologic cytology PT result forms for 2021. PT Proctor failed to sign the result form within the timeframe established by the PT program for eleven of twelve result forms in 2021. 2021 CAP GYNECOLOGIC CYTOLOGY-PAP PT INDIVIDUAL RESULT FORMS include: -Kit #33843584, Slideset #34461 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02/10/2021 -Kit #33843585, Slideset #34461 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02/10/2021 -Kit #33843586, Slideset #34461 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02 /10/2021 -Kit #33843587, Slideset #34460 Ten slides Examinee signature date: 02/09 /2021 PT Proctor signature date: 02/10/2021 -Kit #33843588, Slideset #34460 Ten slides Examinee signature date: 02/09/2021 PT Proctor signature date: 02/10/2021 - Kit #33843589, Slideset #34460 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02/10/2021 -Kit #33843590, Slideset #34460 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02/10/2021 -Kit #33843592, Slideset #34459 Ten slides Examinee signature date: 02/09/2021 PT Proctor signature date: 02/10/2021 -Kit #33843593, Slideset #34459 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02/10/2021 -Kit #34749630, Slideset #34459 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02/10/2021 -Kit #34749631, Slideset #34459 Ten slides Examinee signature date: 02/08/2021 PT Proctor signature date: 02/10/2021 c. The Survey Team reviewed annual gynecologic cytology PT result forms for 2022. PT Proctor failed to sign the result form as required by the PT program for one of two Technical Supervisors in 2022. Technical Supervisor includes: -Technical Supervisor C 2022 CAP GYNECOLOGIC CYTOLOGY-PAP PT INDIVIDUAL RESULT FORM includes: -Kit #35112812, Slideset #34364 Ten slides Examinee signature date: 02/09/2022 PT Proctor signature and date were blank. d. During an interview on June 21, 2022 at 9:50 AM these findings were confirmed by PT Proctor who stated: - Result forms were not faxed to the PT program until after PT Proctor signed the result forms. -"I'm not sure who faxed it to CAP", after being shown the result form for Technical Supervisor C for 2022. 5. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS which stated: -"Fax the result form immediately after the examinee is done. Do not wait until the end of the test event to fax the result form." a. During an interview on June 21, 2022 at 9:50 AM these findings were confirmed by PT Proctor who stated: -PT Proctor batched and faxed the individual result forms together. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 -- 4 of 10 -- The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interview with the Cytoprep Technician the laboratory failed to follow written policies and procedures to ensure positive patient identification during specimen processing and staining. The laboratory failed to label one of one nongynecologic cytology slide with a complete accession number and other unique identifier during specimen processing on June 21, 2022. Findings include: 1. The procedure GENERAL NON-GYN PREPARATION STEPS stated: -"Label with pencil the accession number and other identification on the frosted ends of each slide." 2. During observation of specimen processing and staining on June 21, 2022 at 10:26 AM the Survey Team identified one of one nongynecologic cytology slides without a complete accession number and other unique identifier. Specimen includes: Specimen Identification: Written on Specimen Slide: -C22-000286 (Patient last name), 286 3. During an interview on June 21, 2022 at 10:26 AM these findings were confirmed by Cytoprep Technician who stated that only the patient last name and partial accession number are written on slides for nongynecologic specimens processed on the Hologic ThinPrep 2000 Processor. The label with the full accession number is not placed on the slide until after staining is completed. 4. During an interview on June 21, 2022 at 4:15 PM these findings were reviewed with Laboratory Director/Technical Supervisor A, Acting General Manager and Cytology Supervisor. 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)