International Medical Laboratory

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the laboratory's AAB-Medical Laboratory Evaluation (AAB) proficiency testing (PT) records, seven (7) randomly chosen patients sampling, and interview with the laboratory's technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Rheumatoid Factor (RA/RF) on the third event of 2024 (Q3- 2024). The findings included: 1. The API proficiency program gave an unsatisfactory score of 60% for RA/RF on the third event of 2024 (Q3-2024). 2. The TS and TP confirmed on January 31, 2025, at approximately 11:25 a.m. that the laboratory received the above proficiency score of 60% for RA/RF for the third event of 2024 described in 1. 3. From three (3) out of seven (7) patients test results reviewed, RA/RF test results have been reported during the time the PT survey was unacceptable for which results cannot be assured. 3. Based on the laboratory's annual testing declaration submitted on the day of the survey January 31, 2025, the laboratory tested and reported approximately 15,300 General Immunology tests including RA/RF by the Roche Cobas 6000 instrument. D2098 ENDOCRINOLOGY CFR(s): 493.843(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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's AAB-Medical Laboratory Evaluation (AAB) proficiency testing (PT) records, the Certification and Survey Provider Enhancement Reporting (CASPER) report, and interview with the laboratory technical consultant (TS) on January 31, 2025, at approximately 12:00 p.m., it was determined that the laboratory failed to attain a score of at least 80% of acceptable responses for the HCG analyte for the third event of 2024 (Q3-2024). The findings include: 1. Based on the AAB and CASPER reports the laboratory obtained a score of 40% for the HCG analyte. This score resulted in an unsatisfactory analyte performance for the event. 2. The laboratory's TC affirmedon January 31, 2025 at approximately 12:30 p.m., that the laboratory received a 40% score for the HCG analyte as stated in number 1. 3. The laboratory's testing declaration form signed by the laboratory director on 12/18/2024, stated that the laboratory performed approximately 24,600 Endocrinology samples including HCG, annually. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory's tour, review of laboratory policies and procedures, and interviews with the technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to have and use a Biosafety Cabinet (BSC) when processing microbiology samples (sputum, wounds, etc.). Findings include: 1. The surveyor observed during the laboratory's tour no BSC was available in the microbiology laboratory were sputum and other samples are processed. 2. The TS and TP affirmed by interview that the laboratory lacked a designated BSC for the processing of sputum and other microbiologic specimens possibly containing highly pathogenic organisms. 3. Based on the testing volume declaration the laboratory processed and reported approximately 9,5000 microbiology tests annually. 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 the surveyor's observation during the laboratory tour and interview with the laboratory technical supervisor (TC) and testing personnel (TP); it was determined that the laboratory failed to have procedures and changes in procedures approved, signed, and dated by the current laboratory director before use. The findings included: 1. On the day of the survey January 31, 2025, at approximately 2:00 p.m. the Individualized Quality Control Program (IQCP) microbiology manual in place in the laboratory had not been approved, signed, and dated by the laboratory director. 2. The TC and TP affirmed on December 31, 2025, that the laboratory failed to update protocols for the current IQCP in place for testing performed in the microbiology laboratory and that the effective date and the laboratory director's signature were -- 2 of 4 -- missing. 4. The laboratory's testing declaration form stated that the laboratory processes approximately 9,500 bacteriology patients' samples annually. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour and interviews with the laboratory technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to follow the BBL antibiotic dispenser manufacturer's instructions on the use of a desiccant plate or desiccant materials when storing antibiotics in the freezer or refrigerator. The findings included: 1. The laboratory used three (3) BBL Antibiotic Dispensers in the microbiology laboratory to perform antibiotic susceptibility by the manual Kirby Bauer Method for which none of the three (3) antibiotic dispensers had desiccants. 2. The laboratory did not have available any antibiotic desiccant as recommended by BBL antibiotic dispenser manufacturer. 3. The TS and TP affirmed on December 31, 2025, at approximately 1:30 p.m. that no desiccants were available and used when storing BBL antibiotic discs dispensers in the freezer or refrigerator. 4. According to the testing volume declaration at the time of the survey, the laboratory performed 9,500 Bacteriology susceptibility testing by the manual Kirby Bauer method annually. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, review of the laboratory's bacteriology quality control records, and an interview with laboratory's technical supervisor (TS) and testing personnel (TP) on January 31, 2024, at approximately 2:30 p.m.; it was determined that quality control result for gram staining documentation were missing for 2023 and 2024. Findings include: 1. Based on the surveyor's observation there were no in-house prepared or commercial quality control slides for Gram stain available. 2. Based on review of the laboratory documentation for Gram stain quality control in microbiology, there were no records to document controls were examined weekly. 3. The TC and TP affirmed the Gram stain controls were not used or documented for the years 2023 and 2024. -- 3 of 4 -- D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies and procedures, proficiency testing records, quality control documentation, seven (7) randomly selected patients test records, observation during the laboratory tour, and interviews with the laboratory technical supervisor and testing personnel on January 31, 2025; it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic, analytical, and postanalytic phases of the laboratory testing were monitored. See D2075, D2098, D3007, D5407, D5437, and D5503 -- 4 of 4 --

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, observation and interviews the laboratory failed to establish written policies and procedures to assess the competency of the Technical Supervisors (refer to D5209); failed to establish written policies and procedures for laboratory test processes (refer to D5311 and D5403); failed to follow manufacturer's instructions for gynecologic cytology specimens when using the RESOLUTION BIOMEDICAL CLEARPREP Pap Test (refer to D5411); failed to establish performance specifications when the laboratory modified RESOLUTION BIOMEDICAL CLEARPREP Pap Tests manufacturer's instructions with an alternate method of processing gynecologic cytology specimens (refer to D5423); failed to establish written policies and procedures for the evaluation and comparison of three of three nongynecologic cytology statistics (refer to D5629); failed to establish and follow written policies and procedures for the establishment and reassessment of individual workload limits (refer to D5633, D5635 and D5637); failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of competency records and interview with Laboratory Director/Technical Supervisor A the laboratory failed to establish written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of Technical Supervisors in 2021 and to the date of the survey in 2022. 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 who performed cytology testing. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for Technical Supervisors who performed cytology testing in 2021 and to the date of the survey in 2022. Technical Supervisors include: - Laboratory Director/Technical Supervisor A -Technical Supervisor B 3. During an interview on December 5, 2022 via telephone at 4:00 PM the Laboratory Director /Technical Supervisor A confirmed these findings and stated that the laboratory "does not do pathologist evaluations." D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on lack of instructions to clinicians, review of laboratory test requisitions and interview with Staff B the laboratory failed to ensure that an electronic test requisition solicited the required patient information for cytology Pap Test requests. Required patient information was not solicited on eight of eight electronic Pap Test requisitions sampled from September of 2022. Cross refer to D5311 Findings include: 1. The Survey Team requested of Staff A and Staff B and the laboratory failed to provide instructions to clinicians for submitting required patient information on test requisitions for cytology Pap Tests. Refer to D5311 2. During a review of test requisitions provided by Cytotechnologist and sampled from September 2022, eight of eight electronic Pap Test requisitions failed to solicit the following required patient information for cytology Pap Tests: -The source of the specimen -The patient's last menstrual period -Whether the patient had a previous abnormal report, treatment, or biopsy. Test requisition case numbers include: -705732 -705899 -706084 -706206 -706212 -706328 -706757 -706788 3. During an interview with Staff B on December 6, 2022 at 10:50 AM the paper laboratory test requisition provided to the Survey -- 2 of 16 -- Team was not the same test requisition that was submitted electronically by clinicians for Pap Tests. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of final cytology test reports and corresponding laboratory records the laboratory failed to ensure that cytology specimen information was transcribed accurately into the laboratory information system (LIS) for nine of 40 cytology specimens sampled in September 2022. Findings include: 1. The Survey Team compared 40 final cytology test reports with corresponding laboratory records. Nine of 40 final cytology test reports failed to have accurate specimen information transcribed into the LIS. Specimen information includes: Case #705838 Lab Order Requisition Information: LMP 08/15/22 Cytology Test Report Information: LMP not given Case #705846 Lab Order Requisition Information: Name "Calendaria" Cytology Test Report Information: Name "Candelaria" Case #705810 Lab Order Requisition Information: Specimen Received in ThinPrep vial Cytology Test Report Information: Specimen Received in SurePath vial Case #705868 Lab Order Requisition Information: Date of Collection 09/03/22 Cytology Test Report Information: Date of Collection 09/06/22 Case #705803 Lab Order Requisition Information: Specimen Received in SurePath vial Cytology Test Report Information: Specimen Received in ThinPrep vial Case #706038 Lab Order Requisition Information: LMP 11/11/20 Cytology Test Report Information: LMP 11/11/21 Case #706192 Lab Order Requisition Information: Source cervix Cytology Test Report Information: Source none given Case #706552 Lab Order Requisition Information: Name "Martha" Cytology Test Report Information: Name "Marta" Case #706788 Lab Order Requisition Information: Specimen Received in ThinPrep vial Cytology Test Report Information: Specimen Received in SurePath vial 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 review of laboratory policies and procedures and interview with Staff B the laboratory failed to establish written policies and procedures for the collection, labeling, storage, preservation, transportation and referral of cytology specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the collection, labeling, transportation and referral of nongynecologic cytology specimens. 2. The Survey Team requested and the -- 3 of 16 -- laboratory failed to provide written policies and procedures for the storage, preservation, and transportation of gynecologic cytology specimens. 3. The cytology procedure COLLECTION AND ORDER ACCURACY stated: -"Specimen requirements for Cytologic Evaluation can be found in Pacific Medical Laboratory Directory of Services and is available to all client clinics and physician's offices. The proper techniques for ordering tests, specimen collection, handling, labeling and transporting to the laboratory are also defined in the Directory of Services." a. The Survey Team requested and the laboratory failed to provide the "Directory of Services." 4. During an interview on December 6, 2022 at 11:00 AM when asked for the laboratory's instructions to complete a test requisition, collect and label gynecologic and nongynecologic cytology specimens, preserve and transport cytology specimens, Staff B stated: -"I don't have that. Why do you want something that tells them how to fill out a form? Here is a requisition...it doesn't need a policy." 5. During an interview on December 7, 2022 via telephone at 10:15 AM these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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)

Summary Statement of Deficiencies 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 laboratory records, observation and interviews it was determined that the laboratory failed to follow the manufacturer's instructions for collecting and processing gynecologic cytology specimens using the Resolution Biomedical ClearPrep System (ClearPrep) and failed to validate use of the Becton Dickenson SurePath collection preservative solution. Findings include: 1. The laboratory failed to follow the manufacturer's instructions for collection of Resolution Biomedical ClearPrep gynecologic cytology specimens. 2. The Resolution Biomedical ClearPrep System Operator's Manual Product Insert - Cytology stated: "Proper performance requires use of supplies provided or recommended by Resolution Biomedical, Inc. for use in connection with ClearPrep. Product performance may be compromised if other supplies are used. Materials Required: ClearPrep sample collection vial with 20 ml preservation solution." 3. The Survey Team reviewed 363 ClearPrep gynecologic cytology slide preparations from November 8, 2019 to January 28, 2020. a. The Survey Team observed that 35 of the 363 ClearPrep gynecologic cytology slide preparations indicated on the slide label that the specimens were collected in a SurePath collection preservative. SurePath collection preservative was not recommended by the manufacturer. Specimen Case Numbers Include: -580328 -582492 -582876 -583749 -584540 -585482 -585617 -585627 -585635 -585638 -585641 -585675 -586822 -586833 -587150 -587251 -587265 -587933 -587981 -587998 -588242 -588243 -589447 -589450 -589661 -590313 -590458 -591500 -591867 -591927 -591934 -592105 -592152 -592340 -593215 4. The Survey Team Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- requested and the laboratory failed to provide a validation study for the use of the SurePath specimen collection preservative that was used by the laboratory for collection and processing of Resolution Biomedical ClearPrep System specimens. 5. During an interview on February 05, 2020 at 12:30 PM the Laboratory Director /Technical Supervisor 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 policies and procedures and laboratory records it was determined that the laboratory failed to follow the written policy and procedure for 10% quality control of negative gynecologic specimens. The laboratory failed to review 10% of negative gynecologic slides for 5 of 12 months in 2018 and 5 of 12 months in 2019. Findings include: 1. The laboratory failed to follow the written policy and procedure titled QUALITY CONTROL POLICY FOR CYTOTECHNOLOGISTS. The policy stated: "A minimum of 10% of all gynecological cases interpreted as benign (NILM and inflammatory) will be randomly selected for a prospective review." 2. The Survey Team reviewed annual statistical data for 2018 titled STATISTICS CALENDAR YEAR 2018. a. The statistical records reflected the number of negative cases reviewed and the number of cases reviewed for 10% quality control. The laboratory failed to review 10% of negative gynecologic slides for 5 of 12 months in 2018. Records include: February 2018 -Number of normal cases 203. Number of cases reviewed 19. Percentage of cases reviewed 9. March 2018 -Number of normal cases 224. Number of cases reviewed 20. Percentage of cases reviewed 9. August 2018 - Number of normal cases 265. Number of cases reviewed 23. Percentage of cases reviewed 9. October 2018 -Number of normal cases 209. Number of cases reviewed 19. Percentage of cases reviewed 9. November 2018 -Number of normal cases 171. Number of cases reviewed 15. Percentage of cases reviewed 9. 3. The Survey Team reviewed annual statistical data for 2019 titled STATISTICS CALENDAR YEAR 2019. a. The statistical records reflected the number of negative cases reviewed and the number of cases reviewed for 10% quality control. The laboratory failed to review 10% of negative gynecologic slides for 5 of 12 months in 2019. Records include: January 2019 -Number of normal cases 218. Number of cases reviewed 19. Percentage of cases reviewed 9. February 2019 -Number of normal cases 246. Number of cases reviewed 22. Percentage of cases reviewed 9. June 2019 -Number of -- 2 of 5 -- normal cases 260. Number of cases reviewed 22. Percentage of cases reviewed 8. September 2019 -Number of normal cases 210. Number of cases reviewed 17. Percentage of cases reviewed 8. October 2019 -Number of normal cases 261. Number of cases reviewed 21. Percentage of cases reviewed 8. D5629 CYTOLOGY 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 establish written policies and procedures for the evaluation and comparison of three of three required statistics for gynecologic cytology. The laboratory failed to document three of three required annual statistics for 2018 and 2019. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual statistical evaluation of three required statistics for the gynecologic specimens: - The number of cytology cases examined; - The number of specimens processed by specimen type; - The number of patient cases reported by diagnosis, to include unsatisfactory. 2. The Survey Team requested and the laboratory failed to provide the three required statistics for 2018 and 2019. 3. During an interview on February 5, 2020 at 12:30 PM the Cytotechnologist and the Quality Assessment Manager stated that the statistics compiled included non-negative and negative quality assurance cases that were reviewed, interpreted and reported at another facility. 4. During an interview on February 05, 2020 at 12:30 PM the Laboratory Director/Technical Supervisor confirmed these 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 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: A. Based on review of laboratory records and interviews it was determined the laboratory failed to ensure that 786 of 786 final cytology tests that were reported from another facility in 2018, 2019 and to the date of the survey in 2020 failed to indicate the name and address of the laboratory where the final cytology test was performed. Findings include: 1. The Survey Team reviewed annual statistical data for 2018, 2019 and 2020 titled: -2018 CYTOLOGY STATISTICS SUMMARY -2019 CYTOLOGY STATISTICS SUMMARY -2020 CYTOLOGY STATISTICS SUMMARY - STATISTICS CALENDAR YEAR 2018 -STATISTICS CALENDAR YEAR 2019 - STATISTICS CALENDAR YEAR 2020. a. The statistical records reflected the number and diagnostic category of gynecologic cytology cases that were sent to another facility for final microscopic evaluation and reporting by the Laboratory Director/Technical Supervisor. The case numbers were not provided on the records. Records include: 2018: 91 Non-negative cases 2018: 254 Quality Control (QC) negative cases 2019: 121 Non-negative cases 2019: 281 QC negative cases 2020: 13 Non-negative cases 2020: 26 QC negative cases b. During an interview on February 3, 2020 at 1:20 PM when asked if the Laboratory Director/Technical Supervisor reviewed non-negative slides at another facility, the Cytotechnologist replied "Yes." The Cytotechnologist also stated that 10% negative quality control slides were also sent off site for review by the Laboratory Director/Technical Supervisor. c. During an interview on February 3 at 2:50 PM when asked if the non-negative and quality control slides were reviewed and interpreted off site at another facility the Laboratory Director/Technical Supervisor replied "Yes." 2. During an interview on February 05, 2020 at 12:30 PM the Laboratory Director/Technical Supervisor confirmed that the final test reports for these cases did not reflect the name and address of the facility from which they were reported. B. Based on review of laboratory records it was determined the laboratory failed to ensure that 15 of 155 final cytology test reports from January 1 to the date of the survey in 2020 failed to indicate the name and address of the laboratory where the final cytology test was performed. Findings include: 1. The Survey Team identified 15 of 155 final cytology test reports sampled from January 1 to the date of the survey in 2020 that failed to specify the name and address of the laboratory where the cytology test was performed. Final Test Report Includes: -588063 (reported 01/07/2020) -588557 (reported 01/13/2020) -589027 (reported 01/07/2020) -589029 (reported 01/07/2020) -589030 (reported 01/07/2020) -590320 (reported 01/14/2020) -590372 (reported 01/14/2020) -590740 (reported 01 /16/2020) -590811 (reported 01/16/2020) -590816 (reported 01/14/2020) -591216 (reported 01/16/2020) -592149 (reported 01/21/2020) -592561 (reported 01/27/2020) -593068 (reported 01/27/2020) -593155 (reported 01/27/2020) 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. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, test reports, gynecologic slide preparations and interviews it was determined that the Laboratory Director failed to be responsible for the overall operation and administration of the laboratory, to include assuring compliance with the applicable regulations and ensuring that all the duties of the Laboratory Director were performed. Cross refer to D5411, D5621, D5629, D5805 D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) 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 364 random negative gynecologic cases/slides and the corresponding final cytology test reports from November 2019 - January 2020 and confirmation by the Laboratory Director/Technical Supervisor on February 05, 2020 it was determined that the Technical Supervisor failed to verify the accuracy of 5 gynecologic cytology tests. 1. 591025 01/14/2020 ClearPrep LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS Unsatisfactory for evaluation; too few epithelial cells LABORATORY DIRECTOR/TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; scant 2. 591247 01/17/2020 ClearPrep LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS Unsatisfactory for evaluation; too few epithelial cells LABORATORY DIRECTOR /TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; scant 3. 591287 01/15/2020 ClearPrep LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS Unsatisfactory for evaluation; too few epithelial cells LABORATORY DIRECTOR/TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; scant 4. 591320 01/15 /2020 ClearPrep LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS Unsatisfactory for evaluation; too few epithelial cells LABORATORY DIRECTOR/TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; scant 5. 592103 01/22/2020 ClearPrep LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS Unsatisfactory for evaluation; too few epithelial cells LABORATORY DIRECTOR/TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; scant 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. -- 5 of 5 --

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(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 the third quarter (Q3-2017) of the College Of American Pathologists (CAP) proficiency testing records, random patient sampling test results from 09/01/2017 to 12/02/2018, and interview with the technical consultant on 01/16 /2019 (survey date), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Sex hormone-binding globulin (SHBG) analyte. The findings included: a. Q3-2017, CAP reported an unsatisfactory score of 0% for Sex hormone-binding globulin (SHBG). b. The testing laboratory technical consultant confirmed (401/16/2018 14:30) that the laboratory received the above unsatisfactory proficiency testing score of 0% for (SHBG) testing. c. The accuracy, quality, and reliability of patient results reported during the period of the Q3, 2017 proficiency testing could not be assured. c. The laboratory's testing declaration (01/11 /2019) estimated 30,000 endocrinology tests (includes the SHBG analyte) reported annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, ten (10) random patient sampling test records and an interview with the laboratory technical consultant and bacteriology technical superior, it was determined that the laboratory failed to follow the laboratory's written policy and procedure manual. The findings included: a. Review of the laboratory's Bacteriology policy for the workup and identification of pathogens following the guidelines entitled "TSI - Biochemical Reactions" and "Staph Identification Chart" (see tables for details) showed that the laboratory testing personnel failed to follow the laboratory's policies and procedures. The laboratory bacteriology workup log sheets lacked documentation that biochemical reactions or assays were performed and that only visual morphological notations were transcribed when bacterial organisms were identified and reported. b. For two (2) patient test records sampled on 04/18/2018 and 04/25/2018 the laboratory's bacteriology workup sheet lacked notations of biochemical reactions performed on bacteriological organisms identified. Date ID# Result 4/18/18 485746 Pseudomonas aeruginosa 4/25 /18 486816 SCN c. The technical consultant and bacteriology technical superior confirmed on 01/16/2019 14:20 that the laboratory did not follow the laboratory's written policies and procedures. d. The laboratory's testing declaration (5/21/20015) estimated 14,000 bacteriology tests reported annually. D6122 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: Based on reviews of laboratory personnel documents and patients test records, the lack of laboratory documents, and an interview with the technical consultant and technical superior for the procedures for assessing competency (accuracy, quality, and reliability of results) in test performance, the laboratory failed to include monitoring of recording and reporting of test results. See D5401 -- 2 of 2 --