John Chapman, Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed on August 30, 2024 at John Chapman, LLC, CLIA ID # 19D2111077. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and twice a year verification records and interview with personnel, the laboratory failed to verify the accuracy of Histopathology testing twice per year for two (2) of three (3) times as required. Findings: 1. Review of the laboratory's "Quality Control" policy under section "Independent Slide Quality Control-Bi-annually" revealed "Bi-annually, 5 patients are randomly selected and all slides from that patient's case/cases for that particular day are sent to Dermpath Diagnostic, Atlanta for diagnosis and accuracy." 2. Review of the laboratory's twice per year verification records revealed the laboratory did not have documentation of the verification of the accuracy of Histopathology testing for the second half of 2023 and the first half of 2024. 3. In interview on August 30, 2024 at 9:50 a.m., the Laboratory Director confirmed the twice per year verification was not performed as identified above. 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 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 -- 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: I. Based on observation, review of manufacturer's instructions, and interview with personnel, the laboratory failed to follow the manufacturer's storage requirements for reagents. Findings: 1. Observation by surveyor during the laboratory tour on August 30, 2024 at 8:47 a.m. revealed the following reagents stored in an unlocked cabinet and not stored in a fire safety cabinet: a) StatLab Eosin-Y Alcoholic 0.25% 1 gallon - Quantity: One (1), Manufacturer's storage requirements: "Keep container tightly closed in a fireproof place." 2. In interview on August 30, 2024 at 10 a.m., Histotechnician 1 stated the laboratory did not have a flammable safety cabinet. She confirmed the reagents identified above were not stored in a fireproof place. II. Based on review of patient test records and laboratory temperature logs as well as interview with personnel, the laboratory failed to document the room temperature of the laboratory where supplies and the cryostat were located for six (6) of fourteen (14) days reviewed. Findings: 1. Review of the laboratory's patient logs revealed the laboratory performed patient testing on the following dates: - March 31, 2023 - April 14, 2023 - April 21, 2023 - April 28, 2023 - May 19, 2023 - May 26, 2023 2. Review of the laboratory's 2023 and 2024 temperature logs revealed the laboratory did not document the room temperature of the laboratory on the following dates: - March 31, 2023 - April 14, 2023 - April 21, 2023 - April 28, 2023 - May 19, 2023 - May 26, 2023 3. In interview on August 30, 2024 at 10:09 a.m., the Laboratory Director confirmed the room temperature of the laboratory was not documented on the dates identified above. III. Based on review of patient test records and laboratory temperature logs as well as interview with personnel, the laboratory failed to document the temperature of the cryostat for one (1) of seven (7) days reviewed. Findings: 1. Review of patient test logs revealed the laboratory utilized the cryostat on April 12, 2024 for patient specimens 172 - 185. 2. Review of the laboratory's temperature records revealed the laboratory did not document the temperature of the cryostat on April 12, 2024. 3. In interview on August 30, 2024 at 10:09 a.m., the Laboratory Director confirmed the cryostat temperature was not documented as identified above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: *** Repeat deficiency from previous follow-up survey performed on October 21, 2022.*** Based on observation and interview with laboratory personnel, the laboratory failed to ensure supplies did not exceed their expiration dates in one (1) of one (1) rooms where supplies are stored. Findings: 1. Observation by surveyor during the laboratory tour on August 30, 2024 at 8:47 a.m. revealed the following expired items: a) StatLab 10% Neutral buffered formalin specimen transport container - Lot: 112625, Expiration date: 12/31/2023, Quantity: Fifteen (15) b) StatLab 10% Neutral -- 2 of 4 -- buffered formalin specimen transport container - Lot: 111374, Expiration date: 11/30 /2023, Quantity: One (1) 2. In interview on August 30, 2024 at 8:57 a.m., the Laboratory Director confirmed the supplies identified above were expired. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 21, 2022 at John Chapman, LLC, CLIA ID # 19D2111077. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to have a complete retention policy for slides utilized for Histopathology testing. Findings: 1. Review of the laboratory's "Storage" policy revealed "Mohs' slides will be stored on site for 7 years then be discarded in biohazard," not ten (10) years as required. 2. Review of the laboratory's "Mohs Surgery" policy, approved by the Laboratory Director on June 12, 2021, revealed "All medical records and slides are stored for 7 years and all materials are easily retrievable." 3. In interview on October 21, 2022 at 10:36 am the histotech confirmed the laboratory's policy for storage of Mohs slides did not include ten (10) years as required. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of logs, and interview with personnel, the laboratory failed to label marking dyes stored in secondary containers with the identity, expiration date, and applicable storage information. Findings: 1. Observation by surveyor during the laboratory tour on October 21, 2022 at 10:15 am revealed four (4) unlabeled vials of marking dyes. 2. Review of the laboratory's " 2022 Labeling of a Permanent Secondary Bottle Quality Check" log revealed documented performance January 2022 through October 2022. 3. In interview on October 21, 2022 at 10:36 am the histotech confirmed the secondary vials were not labeled identifying the content, lot number and expiration date. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of logs, and interview with personnel, the laboratory failed to ensure supplies did not exceed expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on October 21, 2022 at 10:15 am revealed the following expired items: a) Ferric subsulfate, Lot 8135, Expiration Date: 2020-05-15, Quantity: one (1) bottle b) Skin Pathology 10% Neutral buffered formalin, Lot 072222, Expiration Date: 2021-12-01, Quantity: six (6) containers 2. Review of the laboratory's records revealed a monthly "Lab Reviewed for Expired Items" log with documented checks January 2022 through October 2022. 3. In interview on October 21, 2022 at 10:36 am the histotech confirmed the identified items were expired. 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 review of random selection of patient test reports, quality assessment logs, and interview with personnel, the laboratory failed to ensure the address of the laboratory performing the test was included on the patient test report for one (1) of six (6) patients reviewed. Findings: 1. Review of the laboratory's "Mohs Quality -- 2 of 3 -- Assessment Three charts Bi-annually" log for 2022 revealed the laboratory reviewed three (3) charts biannually which included a review of patient demographic, site, surgery date, chart and laboratory diagnosis. 2. Review of random selection of patient test reports revealed the test report (visit note) for Case Number: CH22-326 on October 7, 2022 included the address of their other location, not the laboratory that performed the testing. 3. In interview on October 21, 2022 at 11:54 am the histotech stated for the identified patient the incorrect testing location was selected. The histotech confirmed the testing location's address was not included on the identified patient's test report. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to label marking dyes stored in secondary containers with identity, expiration date, and storage requirements. Refer to D5415. 2. The laboratory failed to ensure supplies did not exceed expiration dates. Refer to D5417. D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure final reports included required pertinent information. Refer to D5805. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Refer to D5401. -- 3 of 3 --