Pathology Consultation Services Inc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 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: A. Based on review of laboratory policies and procedures, gynecologic specimen slides and interviews the laboratory failed to follow written policies and procedures to ensure specimen slides were labeled with a unique patient identifier during the preanalytic phase of testing. The laboratory failed to ensure forty of forty consecutive specimen slides from October 2023 were labeled with a unique patient identifier. Findings include: 1. The laboratory failed to follow the procedure THINPREP PROCEDURE, which stated: "PCS (P) label accession number and patient name is written on the corresponding Thin Prep slide." 2. The Survey Team reviewed specimen slides for 40 consecutive patient specimens from October 2023. Forty of 40 specimen slides failed to be labeled with a unique patient identifier. Specimen slides include: Accession number Specimen slide -P23-3510 23-3510 -P23-3511 23-3511 - P23-3512 23-3512 -P23-3513 23-3513 -P23-3514 23-3514 -P23-3515 23-3515 -P23- 3516 23-3516 -P23-3517 23-3517 -P23-3518 23-3518 -P23-3519 23-3519 -P23-3520 23-3520 -P23-3521 23-3521 -P23-3522 23-3522 -P23-3523 23-3523 -P23-3524 23- 3524 -P23-3525 23-3525 -P23-3526 23-3526 -P23-3527 23-3527 -P23-3528 23-3528 - P23-3529 23-3529 -P23-3530 23-3530 -P23-3531 23-3531 -P23-3532 23-3522 -P23- 3533 23-3533 -P23-3534 23-3534 -P23-3535 23-3535 -P23-3536 23-3536 -P23-3537 23-3537 -P23-3538 23-3538 -P23-3539 23-3539 -P23-3540 23-3540 -P23-3541 23- 3541 -P23-3542 23-3542 -P23-3543 23-3543 -P23-3544 23-3544 -P23-3545 23-3545 - P23-3546 23-3546 -P23-3547 23-3547 -P23-3548 23-3548 -P23-3549 23-3549 3. During an interview on November 7, 2023 at 10:15 AM, Staff A confirmed that the 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 -- full accession number was not written on specimen slides prior to processing. Staff A further stated that after processing an adhesive label was placed on the slide with the full accession number. 4. During an interview on November 7, 2023 at 3:00 PM, these findings were confirmed with Cytotechnologist A and the Office Manager. 5. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. B. Based on review of laboratory policies and procedures, observation and interviews the laboratory failed to follow written policies and procedures to ensure positive patient identification during nongynecologic specimen processing. Findings include: 1. The laboratory failed to follow the procedure ACCESSIONING OF CYTOLOGY SPECIMEN, which stated: "Non-gyn specimens are labeled throughout processing with permanent black pens and or labels with the corresponding N or F, year, accession number and last name." 2. During an observation of nongynecologic specimen processing on November 8, 2023 at 10:10 AM, Staff B failed to write N and the year on the specimen centrifuge tube and Hologic PreservCyt Solution specimen vial. Staff B stated that the complete accession number including year was not written on specimens during all phases of specimen processing. Specimen includes: Accession number Number on tube/vial: - N23-778 778 3. During an interview on November 8, 2023 at 11:15 AM, these findings were confirmed with Cytotechnologist A and Staff B. Staff B stated that if a specimen did not come with a label with the full accession number and patient's name "I don't write N and the year or F and the year." 4. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director /Technical Supervisor A. 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 56 laboratory policies and procedures, maintenance records and interviews the laboratory failed to follow three written policies and procedures. Findings include: 1. The laboratory failed to follow the procedure THINPREP 2000 PROCESSOR MAINTENANCE, which stated: "ThinPrep 2000 Processor Maintenance Schedule" "Waste Tubing Replacement (in Pinch Valve) Six Months" a. The Survey Team reviewed maintenance records for the Hologic ThinPrep 2000 Processor from January 2022 to the date of the survey in 2023. The records failed to document the required six month maintenance was performed. b. During an interview on November 6, 2023 at 2:45 PM, these findings were confirmed with Cytotechnologist A and the Office Manager. 2. The laboratory failed to follow the procedure REPROCESSING THINPREP PROCEDURE, which stated: "Prepare a wash solution of sufficient volume to add 30 ml to every ThinPrep Pap Test specimen being processed. The wash solution is made by mixing 9 parts CytoLyt Solution with 1 part glacial acetic acid." "Pellet the contents of the centrifuge tube by centrifugation at 1200 x g for 5 minutes." "Carefully pour off the supernatant from the centrifuge tube to avoid loss of cells." "Pour 30 ml of the CytoLyt Solution and 10% glacial acetic acid mixture into the centrifuge tube and cap securely." a. During an interview on November 7, 2023 at 10:15 AM, Staff A described the process for reprocessing Hologic ThinPrep Paps Tests: 15 mL of specimen was placed into a centrifuge tube. -- 2 of 10 -- CytoLyt Solution was added to bring the volume to 40 mL. The specimen was centrifuged, decanted and the cell button was added to a new PreservCyt Solution Vial. The specimen was then processed on the Hologic ThinPrep 2000 Processor. b. During an interview on November 7, 2023 at 3:00 PM, these findings were confirmed with Cytotechnologist A and the Office Manager. 3. The laboratory failed to follow the procedure QUALITY CONTROL DESCRIPTION, which stated: "Non-Gyn Cytology Staining" "Replace reagents and stains bi-weekly or as needed" a. The Survey Team reviewed records titled NON GYN I DAILY MONITOR (SMEARS) from January 2023 through October 2023. i. The laboratory failed to replace the reagents and stains bi-weekly for 10 of 10 months. Months include: -January, February, March, April, May, June, July, August, September, October b. The Survey Team reviewed records titled NON GYN II DAILY MONITOR (THINPREP /CYTOSPIN) from January 2023 through October 2023. i. The laboratory failed to replace the reagents and stains bi-weekly for 9 of 10 months. Months include: - February, March, April, May, June, July, August, September, October c. During an interview on November 8, 2023 at 10:15 AM, Staff A stated that Staff A changed the reagents and stains monthly. 4. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory policies and procedures and interviews the laboratory failed to follow manufacturer's instructions for reprocessing Hologic ThinPrep Pap Tests following an unsatisfactory result. Findings include: 1. The HOLOGIC THINPREP 2000 SYSTEM OPERATOR'S MANUAL states: "Prepare a wash solution of sufficient volume to add 30 mL to every ThinPrep Pap Test specimen being reprocessed. The wash solution is made by mixing 9 parts CytoLyt Solution with 1 part glacial acetic acid." "Pour 30 mL of the CytoLyt Solution and 10% glacial acetic acid mixture into the centrifuge tube and cap securely." "Using the volume markings on the centrifuge tube, pour the necessary quantity of unused (i.e., containing no patient specimens) PreservCyt Solution to the cells and fill to a final volume of 20mL. Secure cap tightly." 2. During an interview on November 7, 2023 at 10:15 AM, Staff A described the process for reprocessing Hologic ThinPrep Paps Tests: 15 mL of specimen was placed into a centrifuge tube. CytoLyt Solution was added to bring the volume to 40 mL. The specimen was centrifuged, decanted and the cell button was added to a new PreservCyt Solution Vial. The specimen was then processed on the Hologic ThinPrep 2000 Processor. 3. During an interview on November 7, 2023 at 3:00 PM, the Office Manager stated the solution used during specimen reprocessing was a mixture of 160 mL glacial acetic and 786 mL of CytoLyt Solution. 4. The laboratory failed to follow the manufacturer's instructions when reprocessing Hologic ThinPrep Pap Tests. The laboratory failed to use a wash solution made of 9 parts CytoLyt Solution and 1 part glacial acetic acid. 5. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. -- 3 of 10 -- D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of the HOLOGIC THINPREP 2000 SYSTEM OPERATOR'S MANUAL and interviews the laboratory failed to establish performance specifications when the laboratory modified the Hologic ThinPrep test system manufacturer's instructions with an alternate method of reprocessing Hologic ThinPrep Pap Tests following an unsatisfactory result. Findings include: 1. The laboratory failed to establish performance specifications or evidence that the accuracy, precision, analytical sensitivity and specificity of the modified procedure, reportable range of test results or any other performance characteristic was adequate to provide accurate diagnostic interpretations. Refer to D5411 . 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. This STANDARD is not met as evidenced by: Based on review of the HOLOGIC THINPREP 2000 OPERATOR'S MANUAL, maintenance records and interviews the laboratory failed to ensure the required maintenance for one of one Hologic ThinPrep 2000 Processors was performed, as specified by the manufacturer, from January 2022 to the date of the survey in 2023. Findings include: 1. The HOLOGIC THINPREP 2000 OPERATOR'S MANUAL states the following maintenance is to be performed: "Waste tubing replacement - Six months" 2. The Survey Team reviewed maintenance records for the Hologic ThinPrep 2000 Processor from January 2022 to the date of the survey in 2023. The records failed to document the required six month maintenance was performed. 3. During an interview on November 6, 2023 at 2:45 PM, these findings were confirmed with Cytotechnologist A and the Office Manager. 4. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director /Technical Supervisor A. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and -- 4 of 10 -- procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory statistical records and interviews the laboratory failed to follow written policies and procedures for an annual statistical evaluation of one of six required gynecologic laboratory statistics. The laboratory failed to document one of six required gynecologic laboratory statistics for 2022. Findings include: 1. The laboratory failed to follow the procedure ANNUAL STATISTICAL EVALUATION, which stated: "The laboratory performs and documents annual statistical evaluations of the following, for the total caseload and for just the cases signed out at PCS." "Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as LSIL, HSIL, adenocarcinoma, or other malignant neoplasm." 2. The Survey Team requested and the laboratory failed to provide one of six required annual gynecologic laboratory statistics for 2022. Statistic includes: -The number of gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as LSIL, HSIL, adenocarcinoma, or other malignant neoplasms. 3. During an interview on November 6, 2023 at 2:45 PM, these findings were confirmed with Cytotechnologist A and the Office Manager. 4. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5635 CYTOLOGY CFR(s): 493.1274(d)(1)(i) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(i) The workload limit is based on the individual's performance using evaluations of the following: (d)(1)(i)(A) Review of 10 percent of the cases interpreted as negative for the conditions defined in paragraph (e)(1) of this section. (d)(1)(i)(B) Comparison of the individual's interpretation with the technical supervisor's confirmation of patient smears specified in paragraphs (e)(1) and (e)(3) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the laboratory failed to establish and follow written policies and procedures to ensure each Cytotechnologist's maximum workload limit would be based on the individual's performance. The laboratory failed to establish workload limits for two of two Cytotechnologists from January 2022 to the date of the survey in 2023 using the comparison of the Cytotechnologist's interpretations with the Technical Supervisor's confirmation of patient slides. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the -- 5 of 10 -- maximum workload limit for Cytotechnologists would be based on individual performance to include evaluations of the following: -A review of 10 percent of the Cytotechnologist's cases interpreted as negative. -A comparison of the Cytotechnologist's interpretations with the Technical Supervisor's confirmations of patient slides. 2. The Survey Team reviewed records titled TECH PATH COMPARISON for January 2022 to the the date of the survey in 2023. The records identified diagnostic discrepancies between the Cytotechnologists and Technical Supervisors. a. The Survey Team identified one discrepant case for Cytotechnologist A. Case includes: -P23-1931 b. The Survey Team identified one discrepant case for Cytotechnologist B. Case includes: -P23-802 3. The Survey Team reviewed laboratory records titled SEMI ANNUAL PERFORMANCE REVIEW FORM from January 2022 to the date of the survey in 2023. The records documented the results of the review of 10 percent of the Cytotechnologist's cases interpreted as negative and the results of the comparison of the Cytotechnologist's interpretations with the Technical Supervisor's confirmations of patient slides. a. The SEMI ANNUAL PERFORMANCE REVIEW FORM failed to document the two discrepant cases when reassessing maximum workload limits. 4. During an interview on November 8, 2023 at 10:00 AM, Cytotechnologist A confirmed the records failed to include the two discrepant cases on the SEMI ANNUAL PERFORMANCE REVIEW FORM. 5. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, final test reports and gynecologic specimen slides the laboratory failed to follow written policies and procedures to ensure unsatisfactory gynecologic specimen slides were identified and reported as unsatisfactory. The laboratory failed to identify and report two of two gynecologic specimen slides from May 2023 and September 2023 as unsatisfactory. Findings include: 1. The laboratory failed to follow the procedure CRITERIA FOR SPECIMEN ADEQUACY FOR GYN CYTOLOGY, which stated: "Satisfactory for Evaluation indicates the specimens has all of the following:" "Liquid-based preparations: estimated 5,000 well-visualized and well-preserved squamous epithelial cells; at an average concentration of 4 cells per 40X HPF (high power field)." 2. The laboratory failed to identify and report two of two gynecologic specimen slides from May 2023 and September 2023 as unsatisfactory. Specimen slides include: -P23-1563 -P23-3281 D5659 CYTOLOGY CFR(s): 493.1274(e)(6) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(6) Corrected reports issued by the laboratory indicate the basis for correction. -- 6 of 10 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, corrected test reports and interviews the laboratory failed to establish written policies and procedures to ensure corrected test reports indicated the basis for correction on the test report. Two of two corrected test reports from May 2021 failed to indicate the basis for correction on the corrected test report. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure corrected test reports indicated the basis for correction on the test report. 2. The Survey Team reviewed two corrected test reports from May 2021. a. Two of two corrected test reports failed to indicate the basis for correction on the corrected test report. Reports include: -P21-1713 -P21-1859 3. During an interview on November 7, 2023 at 10:35 AM, these findings were confirmed with the Office Manager. 4. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of final test reports and interviews the laboratory failed to maintain duplicates of two of two original final test reports from May 2021 when a correction was made to the original final test report. Findings include: 1. The Survey Team requested and the laboratory failed to provide a duplicate of the original final test report for two of two corrected test reports. Reports include: -P21-1713 -P21-1859 2. During an interview on November 7, 2023 at 10:35 AM, the Office Manager stated the laboratory did not keep duplicates of original test reports when corrections were made to the original final test report. 3. During an interview on November 8, 2023 at 11:45 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, gynecologic specimen slides, observation and interviews the laboratory failed to have a Laboratory Director who provides overall management and direction in accordance with 493.1445 of this subpart. The Laboratory Director failed to be responsible for the overall operation and administration of the laboratory and for assuring compliance with applicable regulations (refer to D6079); failed to ensure quality assessment -- 7 of 10 -- programs were established to assure the quality of laboratory services and identify failures in quality as they occur (refer to D6094); and failed to ensure the competency of two of two Staff (refer to D6103). D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, gynecologic specimen slides and interviews the Laboratory Director failed to be responsible for the overall operation and administration of the laboratory and for assuring compliance with applicable regulations. Findings include: 1. The Laboratory Director failed to provide direction and oversight to ensure all laboratory polices and procedures were followed. Refer to D5401 2. The Laboratory Director failed to provide direction and oversight to ensure manufacturer's instructions were followed for reprocessing Hologic ThinPrep Pap Tests. Refer to D5411 3. The Laboratory Director failed to provide direction and oversight to ensure performance specifications were established when the laboratory modified the Hologic ThinPrep test system manufacturer's instructions with an alternate method of reprocessing Hologic ThinPrep Pap Tests. Refer to D5423 4. The Laboratory Director failed to provide direction and oversight to ensure the required maintenance for the Hologic ThinPrep 2000 Processor was performed, as specified by the manufacturer. Refer to D5429 5. The Laboratory Director failed to provide direction and oversight to ensure each Cytotechnologist's maximum workload limit would be based on the individual's performance. Refer to D5635 6. The Laboratory Director failed to provide direction and oversight to ensure unsatisfactory gynecologic specimen slides were identified and reported as unsatisfactory. Refer to D5655 7. The Laboratory Director failed to provide direction and oversight to ensure corrected test reports indicated the basis for correction on the test report. Refer to D5659 8. The Laboratory Director failed to provide direction and oversight to ensure duplicates of original final test reports were maintained when a correction was made to the original final test report. Refer to D5821 D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 8 of 10 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the Laboratory Director failed to ensure quality assessment programs were established to assure the quality of laboratory services and identify failures in quality as they occur. Findings include: 1. The Laboratory Director failed to ensure the establishment of written policies and procedures for a quality assessment program for all phases of cytology testing. 2. The Laboratory Director failed to provide records of an established quality assessment program and failed to identify failures in quality as they occurred in 2021, 2022 and to the date of the survey in 2023. a. The Laborator Director failed to provide records to document an established program to monitor specimen slides to ensure specimen slides were labeled with a unique patient identifier. Refer to D5203 b. The Laboratory Director failed to provide records to document an established program to monitor the maintenance of the Hologic ThinPrep 2000 Processor to ensure the required maintenance was performed. Refer to D5429 c. The Laborator Director failed to provide records to document an established program to monitor the Cytotechnologist's workload assessment to ensure each Cytotechnologist's maximum workload limits would be based on the individual's performance. Refer to D5635 d. The Laborator Director failed to provide records to document an established program to monitor corrected test reports to ensure corrected test reports indicated the basis for correction on the test report. Refer to D5659 e. The Laborator Director failed to provide records to document an established program to monitor test reports to ensure duplicates of original test reports were maintained when a correction was made to the original final test report. Refer to D5821 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 review of laboratory policies and procedures, laboratory records, observation and interviews the Laboratory Director failed to ensure established competency policies and procedures were followed and effective to assess, monitor and maintain the competency of the Technical Supervisor performing cytology duties. Findings include: 1. The Laboratory Director failed to identify training needs for Staff B during nongynecologic specimen processing. a. The Survey Team reviewed records titled CYTO PREPARATORY PERSONNEL TRAINING for Staff B from 2021, 2022 and 2023. The records stated Staff B had acceptable performance when performing specimen processing. Refer to D5203 2. The Laboratory Director failed to identify training needs for Staff A when reprocessing Hologic ThinPrep Pap Tests. a. The Survey Team reviewed records titled PERSONAL COMPETENCY ASSESSMENT for Staff A from 2021 and 2022. The records stated Staff A had acceptable performance when performing specimen reprocessing. Refer to D5401, D5411 D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) -- 9 of 10 -- The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the microscopic review of 358 negative gynecologic cases/slides from May 2023 and August through October 2023 the Technical Supervisor failed to verify the accuracy of three gynecologic cytology tests. 1. P23-3261 09/27/2023 Imaged ThinPrep Pap Test (I-TPPT) LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion TECHNICAL SUPERVISOR A DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion 2. P23-1563 05/04/2023 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory. Insufficient Cellularity. TECHNICAL SUPERVISOR A DIAGNOSIS: Unsatisfactory. Insufficient Cellularity. 3. P23-3281 09//2023 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory. Insufficient Cellularity. TECHNICAL SUPERVISOR A DIAGNOSIS: Unsatisfactory. Borderline Cellularity and Partially Obscured by Lubricant. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 10 of 10 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 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 it was determined that the laboratory failed to establish written policies and procedures to ensure positive patient identification during nongynecologic specimen processing. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for positive patient identification during nongynecologic specimen processing. 2. During observation of nongynecologic specimen processing on June 29, 2021 at 1:05 PM, Cytology Supervisor /Cytototechnologist A failed to label three of three nongynecologic specimen containers with the complete patient identifier accession number. Specimens include: Accession #: # Written on Specimen: -N21-514 514 -N21-515 515 -N21-516 516 a. During further observation it was determined that the laboratory failed to label thee of three previously processed specimen centrifuge tubes with the complete patient identifier accession number. Specimens include: Accession #: # Written on Specimen: -N21-511 511 -N21-512 512 -N21-513 513 3. During an interview on June 30, 2021 at 12:10 PM, the Laboratory Director/Technical Supervisor A and Cytology Supervisor/Cytotechnologist A confirmed these findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors. The laboratory failed to assess the competency of four of four Technical Supervisors in 2019, 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for four of four Technical Supervisors in 2019, 2020 and to the date of the survey in 2021. Technical Supervisors include: -Laboratory Director/Technical Supervisor A - Technical Supervisor B -Technical Supervisor C -Technical Supervisor D 3. During an interview on June 30, 2021 at 12:10 PM, the Laboratory Director/Technical Supervisor A and Cytology Supervisor/Cytotechnologist A confirmed these findings. B. Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of Cytotechnologists. The laboratory failed to assess the competency of two of two Cytotechnologists in 2019, 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Cytotechnologists for all duties performed. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for two of two Cytotechnologists in 2019, 2020 and to the date of the survey in 2021. Cytotechnologists include: -Cytology Supervisor/Cytotechnologist A - Cytotechnologist B a. Laboratory records titled PERFORMANCE REVIEW failed to include competency assessments for required duties in all phases of testing. 3. During an interview on June 30, 2021 at 12:10 PM, the Laboratory Director/Technical Supervisor A and Cytology Supervisor/Cytotechnologist A confirmed these findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of 51 laboratory policies and procedures and interviews it was determined that the laboratory failed to ensure that 23 of 51 written policies and procedures were approved, signed and dated by the Laboratory Director prior to use. Findings include: 1. The Laboratory Director failed to sign and date 23 of 51 written policies and procedures prior to use. Procedures include: -Requirements for Specimen Collection, Submission and Processing -Directions for Cervical - Vaginal Smear - ThinPrep Imaging Procedure -Reprocessing ThinPrep Procedure -Microscopic Interpretation -Meditech Reporting System -Criteria for Specimen Adequacy for GYN Cytology -Quality Control of Cytology Interpretation -Retrospective Review - Corrected Report Form -Cyto-Histo Correlation -ThinPrep Imager Processor Maintenance -Evaluating Stain Quality -H&E Stain Procedure and Maintenance Schedule -Cytology Instrument Maintenance -Non-GYN ThinPrep Procedure - -- 2 of 6 -- Cytospin Procedure -Cytotechnology Competency Assessment Policy -Cyto- Histo Preparatory Personnel Training -Laboratory Infection Control -Blood, Infectious Waste Spill Procedure -Formaldehyde Disposal -Annual Statistical Evaluation 2. During an interview on June 29, 2021 at 9:40 AM, the Cytology Supervisor /Cytotechnologist A explained that all written procedures were initially signed as "adopted" by the Cytology Supervisor/Cytotechnologist A and the Laboratory Director /Technical Supervisor A signed the procedures as being "reviewed" at a later date. 3. During an interview on June 30, 2021 at 12:10 PM, the Laboratory Director/Technical Supervisor A and Cytology Supervisor/Cytotechnologist A confirmed these findings. D5621 CYTOLOGY CFR(s): 493.1274(c)(1) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (1) A review of slides from at least 10 percent of the gynecologic cases interpreted by individuals qualified under 493.1469 or 493.1483, to be negative for epithelial cell abnormalities and other malignant neoplasms (as defined in paragraph (e)(1) of this section). (c)(1)(i) The review must be performed by an individual who meets one of the following qualifications: (c)(1)(i)(A) A technical supervisor qualified under 493. 1449(b) or (k). (c)(1)(i)(B) A cytology general supervisor qualified under 493.1469. (c)(1)(i)(C) A cytotechnologist qualified under 493.1483 who has the experience specified in 493.1469(b)(2). (c)(1)(ii) Cases must be randomly selected from the total caseload and include negatives and those from patients or groups of patients that are identified as having a higher than average probability of developing cervical cancer based on available patient information. (c)(1)(iii) The review of those cases selected must be completed before reporting patient results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures to detail how at least 10 percent of the gynecologic cases interpreted to be negative would be randomly selected for review and how they would be reviewed before reporting patient results Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how at least 10 percent of the gynecologic cases/slides interpreted to be negative for epithelial cell abnormalities would be randomly selected for review. a. During an interview on June 29, 2021 at 1:00 PM the Survey Team asked the Cytology Supervisor /Cytotechnologist A if there was a written procedure to determine how the cases/slides were randomly selected. The Cytology Supervisor/Cytotechnologist A replied "no." b. The Cytology Supervisor/Cytotechnologist A explained that all cases/slides evaluated by the Cytotechnologist were sent to a pathologist but it was known by the Cytotechnologist which cases/slides would and would not be reviewed by a pathologist. 2. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the review of cases/slides selected would be completed before reporting patient results. a. During an interview on June 29, 2021 at 1:00 PM the Cytology Supervisor/Cytotechnologist A explained that all negative cases /slides evaluated by the Cytotechnologist were sent to a pathologist for review but the Cytotechnologist released some cases prior to being sent to the pathologist. D5629 CYTOLOGY -- 3 of 6 -- CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to follow written policies and procedures for the evaluation and comparison of six of six laboratory statistics. The laboratory failed to document three of six required annual statistics for 2019 and 2020. Findings include: 1. The laboratory failed to follow the written procedure ANNUAL STATISTICAL EVALUATION which stated: "The laboratory performs and documents an annual statistical evaluation of the following: -Cytology cases examined -Specimens processed by specimen type -Patient cases reported by diagnosis - Gynecologic cases with a diagnosis of ASC-US, LSIL, HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison - Gynecologic cases where cytology and histology are discrepant -Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as LSIL, HSIL, adenocarcinoma, or other malignant neoplasm" 2. The Survey Team requested and the laboratory failed to provide three of six required annual statistics for 2019 and 2020: -number of total cytology cases examined -number of specimens by specimen type -number of specimens by diagnosis 3. During an interview on June 28, 2021 at 9:45 AM, Cytology Supervisor/Cytotechnologist A stated "the statistics are wrong and we are still working on it." 4. During an interview on June 30, 2021 at 12: 10 PM, the Laboratory Director/Technical Supervisor A and Cytology Supervisor /Cytotechnologist A confirmed that the statistics on the ANNUAL STATISTICAL REPORT document failed to include the total number of cases that were reported at the laboratory being surveyed. 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 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. -- 4 of 6 -- This STANDARD is not met as evidenced by: Based on review of cytology test reports and interviews it was determined the laboratory failed to ensure that 12 of 200 cytology test reports from April through June 2021 indicated the name and address of the laboratory where the test was performed. Findings include: 1. Twelve of 200 cytology test reports sampled from April through June 2021 failed to indicate the name and address of the laboratory where the cytology testing was performed. Test Reports include: -P21-1204 -P21- 1207 -P21-1216 -P21-1218 -P21-1220 -P21-1225 -P21-1228 -P21-1230 -P21-1231 - P21-1237 -P21-1400 -P21-2051 2. During an interview on June 28, 2021 at 9:50 AM, Cytology Supervisor/Cytotechnologist A stated "we had a problem with the location on the test reports but it was corrected on March 28, 2021." 3. During an interview on June 30, 2021 at 12:10 PM, the Laboratory Director/Technical Supervisor A and Cytology Supervisor/Cytotechnologist A confirmed these findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to have a Laboratory Director who provides overall management and direction in accordance with 493.1445 of this subpart. The Laboratory Director failed to fulfill the responsibility for the overall operation of the laboratory and failed to ensure compliance with applicable regulations (refer to D6079); and failed to ensure that written policies and procedures were established to assess, monitor and maintain the competency of four of four Technical Supervisors and two of two Cytotechnologists (refer to D6103). D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the Laboratory Director failed to assure compliance with the applicable regulations and ensure that all the duties of the Laboratory Director were performed. Cross Refer to D5407, D5621, D5629, D5805 -- 5 of 6 -- D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 review of laboratory policies and procedures, laboratory records and interview it was determined that the Laboratory Director failed to ensure that written policies and procedures were established to assess, monitor and maintain the competency of four of four Technical Supervisors and two of two Cytotechnologists. Cross refer to D5209 D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/05/2021. The findings were reviewed with the cytotechnologist general supervisor at the conclusion of the survey. The laboratory was found in compliance with a standard-level deficiency cited. 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 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 review of records and interview with the cytotechnologist general supervisor, the laboratory failed to ensure patient test reports included the name and address of the laboratory location for 5 of 5 patient reports. Findings include: (1) On 02/05/2021, the surveyors reviewed 5 patient test reports and identified the reports did not accurately reflect the name and address where slide interpretations had been performed as follows: (a) Report #1 - A Pap smear slide interpretation was performed with the results reported on 11/03/2020: (i) The surveyors identified that the name and address of the microscopic examination on the report was "Norman Regional Hospital 901 N. Porter Norman OK 73071", which did not reflect where the test was performed; (ii) Surveyor #1 reviewed the report with the cytotechnologist general supervisor and asked the cytotechnologist general supervisor where the microscopic examination was performed. The cytotechnologist general supervisor stated on 02/05 /2021 at 01:50 pm, the microscopic examination had been performed at Pathology 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 -- Consultation Services 501 Alameda, Suite B, Norman OK 73071. (b) Report #2 - A Pap smear slide interpretation was performed with the results reported on 11/03/2020: (i) The surveyors identified that the name and address of the microscopic examination on the report was "Norman Regional Hospital 901 N. Porter Norman OK 73071", which did reflect where the test was performed; (ii) Surveyor #1 reviewed the report with the cytotechnologist general supervisor and asked the cytotechnologist general supervisor where the microscopic examination was performed. The cytotechnologist general supervisor stated on 02/05/2021 at 01:51 pm, the microscopic examination had been performed at Pathology Consultation Services 501 Alameda, Suite B, Norman OK 73071. (c) Report #3 - A Pap smear slide interpretation was performed with the results reported on 11/03/2020: (i) The surveyors identified that the name and address of the microscopic examination on the report was "Norman Regional Hospital 901 N. Porter Norman OK 73071", which did reflect where the test was performed; (ii) Surveyor #1 reviewed the report with the cytotechnologist general supervisor and asked the cytotechnologist general supervisor where the microscopic examination was performed. The cytotechnologist general supervisor stated on 02/05/2021 at 01:52 pm, the microscopic examination had been performed at Pathology Consultation Services 501 Alameda, Suite B, Norman OK 73071. (d) Report #4 - Histopathology grossing was performed with the results reported on 02/03/2021: (i) The surveyors identified that the name and address of the grossing on the report was "PATHOLOGY CONSULTATION SERVICES 501 Alameda, Suite B, NORMAN, OK 73071", which did not reflect where the test was performed; (ii) Surveyor #1 reviewed the report with the cytotechnologist general supervisor and asked the cytotechnologist general supervisor where the grossing was performed. The cytotechnologist general supervisor stated on 02/05/2021 at 01:53 pm, the grossing had been performed at Norman Regional Hospital 901 N. Porter, Norman, OK 73071. (e) Report #4 - Histopathology grossing and slide interpretation were performed with the results reported on 02/06/2021: (i) The surveyors identified that the name and address of the grossing and slide interpretation on the report was "PATHOLOGY CONSULTATION SERVICES 501 Alameda, Suite B, NORMAN, OK 73071", which did not reflect where the test was performed; (ii) Surveyor #1 reviewed the report with the cytotechnologist general supervisor and asked the cytotechnologist general supervisor where the grossing and slide interpretation were performed. The cytotechnologist general supervisor stated on 02/05/2021 at 01:55 pm, the grossing and slide interpretation had been performed at Norman Regional Laboratory Services Surgical Pathology 901 N. Porter; Box 1308, Norman, OK 73070-1308. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The survey was performed on 11/20/18. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the cytotechnologist at the conclusion of the survey. 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 records, manufacturer's instructions, and interview with the cytotechnologist, the laboratory failed to ensure the manufacturer's environmental specifications were met for the instruments used in the laboratory. Findings include: HUMIDITY (1) At the beginning of the survey, the cytotechnologist stated to the surveyor the laboratory performed histology and cytology testing; (2) The surveyor reviewed the manufacturer's humidity specifications for the instruments used to process the samples received for testing: (a) Thin Prep 2000: Used to prepare patient Pap smears for screening. The manufacturer required a humidity of 20-90%; (b) Cellient Automated Cell Block System: Used for automated filtration and preparation of sample cell blocks. The manufacturer required a humidity of 20-80%; (c) Thin Prep Imaging System: The computerized analysis system used to read ThinPrep smears. The manufacturer required a humidity of 20-80%. (3) The surveyor then reviewed the humidity records from 9 months (February, August, November, and December 2017; and January, April, May, June, and September 2018). The surveyor identified on 8 of 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 166 days of patient testing reviewed, the manufacturers' humidity requirement had not been met: (a) December 2017: 7 of 20 days of patient testing: (i) 0%: Days 11,12,13,14,15 (ii) 15%: Days 6,8 (b) January 2018: 1 of 22 days of patient testing: (i) 3%: Day 30 (4) The surveyor reviewed the findings with the cytotechnologist, who stated to the surveyor the laboratory failed to ensure the manufacturers' humidity requirement was met on the days listed above. REFRIGERATOR TEMPERATURE (1) The surveyor identified the Sears Coldspot Mini-fridge located in the laboratory. Inside the refrigerator were 2 boxes of Histogel. The manufacturer required a storage temperature of 2-8 degrees C (Centigrade); (2) The surveyor asked the cytotechnologist how the Histogel material was used. The cytotechnologist stated to the surveyor the material was used to make cell blocks when a small amount of sample was submitted for testing; (3) The surveyor then reviewed temperature records for the refrigerator from 9 months (February, August, November, and December 2017; and January, April, May, June, and September 2018). The surveyor identified on 15 of the 166 days of patient testing reviewed, the refrigerator was 1 degree C, which was lower than the manufacturer's storage temperature requirement, as follows: (a) December 2017: 5 of 20 days of patient testing: (i) 1 degree C: Days 6,12,13,14,20 (b) November 2017: 1 of 20 days of patient testing: (i) 1 degree C: Day 7 (c) January 2018: 8 of 22 days of patient testing: (i) 1 degree C: Days 2,3,8,9,10,17,18,19 (d) May 2018: 1 of 22 days of patient testing: (i) 1 degree C: Day 31 (4) The surveyor reviewed the findings with the cytotechnologist, who stated to the surveyor the laboratory failed to store testing materials, as required by the manufacturer. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 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 procedures, observation, review of glass slides and interviews it was determined that the laboratory failed to follow written policies and procedures to ensure the positive identification of 116 of 179 gynecologic cytology glass slides sampled from 10/2/17 to 1/24/18. Findings include: 1. The procedure titled ACCESSIONING OF CYTOLOGY SPECIMENS stated "LABELING SLIDES. Gynecologic and Non Gynecologic slides are labeled with permanent black pens with the corresponding accession number". 2. The procedure titled THINPREP PROCEDURE stated "3. PCS (P) number and patient name is written on the corresponding ThinPrep slide". 3. On 1/23/18 at 10:35 AM the Survey Team observed that the slides were not labeled with a unique identifier (accession number) to ensure positive patient identification. 4. The Survey Team identified 116 of 179 slides that failed to have a unique identifier on the patient slide: Accession Number on Labeling on the the Test Requisition Glass Slide P17-3292 3292 P17-4371 4371 P17-4684 4684 P17-4700 4700 P17-4701 4701 P17-4703 4703 P17-4706 4706 P17-4707 4707 P17-4709 4709 P17-4711 4711 P17-4712 4712 P17-4717 4717 P17-4720 4720 P17- 4721 4721 P17-4730 4730 P17-4732 4732 P17-5052 5052 P17-5056 5056 P17-5057 5057 P17-5059 5059 P17-5061 5061 P17-5065 5065 P17-5067 5067 P17-5070 5070 P17-5072 5072 P17-5073 5073 P17-5076 5076 P17-5078 5078 P17-5079 5079 P17- 5080 5080 P17-5082 5082 P17-5085 5085 P17-5086 5086 P17-5090 5090 P17-5135 5135 P17-5136 5136 P17-5138 5138 P17-5141 5141 P17-5142 5142 P17-5420 5420 P17-5421 5421 P17-5428 5428 P17-5429 5429 P17-5474 5474 P17-5480 5480 P17- 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 -- 5481 5481 P17-5484 5484 P17-5490 5490 P17-5491 5491 P17-5494 5494 P17-5496 5496 P17-5504 5504 P17-5506 5506 P17-5548 5548 P17-5549 5549 P17-5551 5551 P17-5554 5554 P17-5924 5924 P17-5926 5926 P17-5927 5927 P17-5932 5932 P17- 5933 5933 P17-5936 5936 P17-5943 5943 P17-5944 5944 P17-5946 5946 P17-5951 5951 P17-5952 5952 P17-5953 5953 P17-5959 5959 P17-5982 5982 P17-5987 5987 P17-5989 5989 P17-5993 5993 P17-5995 5995 P17-5996 5996 P17-6000 6000 P18- 0005 5 P18-0006 6 P18-0010 10 P18-0013 13 P18-0014 14 P18-0016 16 P18-0022 22 P18-0025 25 P18-0027 27 P18-0031 31 P18-0032 32 P18-0036 36 P18-0042 42 P18- 0043 43 P18-0044 44 P18-0078 78 P18-0080 80 P18-0081 81 P18-0087 87 P18-0180 180 P18-0182 182 P18-0184 184 P18-0185 185 P18-0186 186 P18-0191 191 P18- 0192 192 P18-0194 194 P18-0195 195 P18-0200 200 P18-0201 201 P18-0202 202 P18-0205 205 P18-0206 206 P18-0208 208 P18-0210 210 P18-0212 212 P18-0214 214 P18-0215 215 P18-0217 217 4. These findings were confirmed by Cytotechnologist A on 1/23/18 at 3:30 PM. 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)