Pathology Laboratory, Inc, The

Summary Statement of Deficiencies D0000 A Recertification survey was performed on July 19, 2024 at The Pathology Laboratory, INC, CLIA ID # 19D1073159. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5779

Summary Statement of Deficiencies D0000 A Certification survey was performed on November 30, 2022 at The Pathology Laboratory, INC, CLIA ID # 19D1073159. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: I. Based on observation by surveyor 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 November 30, 2022 at 9:01 am revealed the following expired items: a) CDI Tissue Marking Dye, Yellow, Lot 20282, Expiration date: 2022-10-31, Quantity: one (1) bottle b) a/m Copper Control Slide, Lot 644538J3, Expiration Date: 2022-07-31, Quantity: one (1) 3. In interview on November 30, 2022 at 9:25 am, Compliance Personnel 2 confirmed the yellow marking dye was expired. 4. In interview on November 30, 2022 at 9:55 am, Compliance Personnel 1 confirmed the copper control slide was expired. II. Based on observation by surveyor, review of manufacturer's package insert, patient test logs, and interview with personnel, the laboratory failed to ensure an expired copper control slide was not utilized for Histopathology patient testing for four (4) patients. Findings: 1. Observation by surveyor during the laboratory tour on November 30, 2022 at 9:01 am revealed an expired copper control slide. Refer to D5417 I. 2. Further observation by surveyor during the laboratory tour on November 30, 2022 revealed "Revalidated 7 /20/22 Expires 7/20/23" written on the outside of the copper control slide box. 3. In interview on November 30, 2022 at 9:55 am , Compliance Personnel 1 stated 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 6 -- control slides are revalidated and expiration date extended for an additional year. 4. Review of the manufacturer's package insert revealed the manufacturer did not include information related to revalidation of slides or extension of expiration dates. 5. Review of patient test logs revealed the following four (4) patients were reported following the use of an expired copper control slide: a) Received: September 7, 2022; Case T22-6110 b) Received September 30, 2022; Case S22-6841 c) Received October 6, 2022; Case S22-6987 d) Received October 24, 2022; Case S22-7436 6. In interview on November 30, 2022 at 9:55 am, Compliance Personnel 1 confirmed an expired control slide was utilized for the identified patients. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control logs, patient test records, and interview with personnel, the laboratory failed to ensure testing personnel documented the stain quality and reactivity of the iron control slide for histopathology testing for one (1) of twenty two (22) patients reviewed. Findings: 1. Review of quality control logs and patient test records revealed the iron control slide's quality and reactivity were not documented on the laboratory's "Special Stain Quality Control Sheet 06/09/22" for Patient N22-3204. 2. In interview on November 30, 2022 at 11:41 am, Compliance Personnel 1 and 2 confirmed the stain quality and reactivity of the iron control slide were not documented by the testing personnel for the identified patient. D5781

Summary Statement of Deficiencies D0000 A Certification survey was performed on March 17, 2021 at The Pathology Laboratory, INC, CLIA ID # 19D1073159. 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 gynecology cytology policy, case review logs, and interview with personnel, the laboratory failed to follow their policy for cytology five year retrospective review discrepancies. Findings: 1. Review of the laboratory's "GYN Cytology: Five Year Retrospective Review" policy revealed the following

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Reliapath LLC - CLIA # 19D1073159 on June 27, 2018. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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, record review, and interview with laboratory personnel, the laboratory failed to ensure that Immunohistochemical and Routine Staining Materials are not used beyond their expiration dates. Findings: 1. Observation by the surveyor during the tour of the laboratory on June 27, 2018 revealed the following expired items in place for patient testing: One (1)/ 7 milliliter (ml) bottle of Cell Marque CD31 (JC70) Immunohistochemical Material - lot 1516303A with an expiration date of 2018-05 One (1)/ 7 ml bottle of Cell Marque PSA (ER-PR8) Immunohistochemical Material - lot 1607709F with an expiration date of 2018-02 One (1)/ 100 ml bottle of American Master Tech 1% Potassium Permanganate (utilized in the reticulin stain) - lot 17120738 with an expiration date of 2018-06-07. 2. Review of a random selection of patient test records from March 21, 2018 through June 25, 2018 revealed the following patients were tested and reported utilizing the expired items cited above: a) Cell Marque CD31 (JC70) Immunohistochemical Material - lot 1516303A with an expiration date of 2018-05: Patient 25 reported on June 22, 2018. b) Cell Marque PSA (ER-PR8) Immunohistochemical Material - lot 1607709F with an expiration date of 2018-02: Patient 26 reported on March 26, 2018. Patient 27 reported on May 10, 2 018. Patient 28 reported on May 15, 2018. Patient 29 reported on June 18, 2018. c) American Master Tech 1% Potassium Permanganate (utilized in the reticulin stain) - 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 -- lot 17120738 with an expiration date of 2018-06-07: Patient 30 reported on June 19, 2018. Patient 31 reported on June 22, 2018. Patient 32 reported on June 27, 2018. 3. Interview with personnel 6 on June 27, 2018 confirmed the laboratory tested and reported patient test results utilizing the expired items cited above. 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 record review and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required for accurate and reliable results. Findings: 1. The laboratory failed to ensure that Immunohistochemical and Routine Staining Materials are not used beyond their expiration dates. Refer to D5417. 2. Interview with personnel 6 on June 27, 2018 confirmed the laboratory tested and reported patient test results utilizing the expired items cited above. -- 2 of 2 --