Bridgeport Hospital Laboratory

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and telephone staff interview, the laboratory failed to test proficiency testing (PT) samples in the same manner as patient samples in the subspecialty of Mycobacteriology. Findings include: 1. Record review on 2/15/2024 of the laboratory's PT evaluation report from the College of American Pathologists revealed the following survey with an unacceptable result for Acid Fast Bacilli (AFB) smear and Mycobacteria Screen: Year/Event Sample ID Grade/Score 2023/E1-B E1- 07 Unacceptable. 2. Record review on 2/29/2024 of the laboratory's 'BH AFB cultures on the Versatrek ESP system' procedure manual for "Handling of AR negative Flagged Bottles" revealed the following: a. "Incubate the bottle in the AFB incubator and check for turbidity at least 2 times per week until the culture has been incubated a total of 35 days." b. "At 35 days, repeat AR staining prior to reporting." 3. Record review on 2/29/2024 of the laboratory's Beaker electronic work up documentation revealed the lack of documentation of a complete work up performed including the preliminary findings for the PT sample E1-07 for twice a week for 35 days. 4. Telephone interview on 2/29/2024 at 1:30 PM with the microbiology general supervisor (MGS) confirmed: a. The laboratory failed to follow the 'BH AFB cultures on the Versatrek ESP system' procedure as listed in 2a and 2b above. b. The MGS 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 -- further commented that PT samples workup was noted on the sample bottle itself but if this was a patient, there would have been a paper trail of the workup documentation. 5. The laboratory performs 870 AFB tests annually in the subspeciality of Mycobacteriology. D2035 MYCOBACTERIOLOGY CFR(s): 493.825(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to properly investigate and take remedial action when unacceptable Proficiency Testing (PT) results were obtained in the subspecialty of Mycobacteriology. Findings include: 1. Record review on 2/15/2024 of the laboratory's PT evaluation report from the College of American Pathologists revealed the following survey with an unacceptable result for Acid Fast Bacilli (AFB) smear and Mycobacteria Screen: Year/Event Sample ID Grade/Score 2023/E1-B E1-07 Unacceptable. 2. Record review on 2/15/2024 of the laboratory's 'Qualitative Laboratory Result-CAP Survey Action Report' revealed the following

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor observation, record review and staff interview, the histopathology laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1273, and 493.1281 through 493.1299. The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results. Refer to D5311, D5391, D5403, and D5429. 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 record review and staff interview, the laboratory failed to establish written policies and procedures for the use of tampers for tissue specimen processing in the subspecialty of histopathology. Findings include: 1. Staff interview with the laboratory director (LD) on 1/22/19 at 9:56 AM revealed, a) 2 of 2 patients had their Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- tissue blocks cross contaminated during the tissue embedding process on 12/4/18. LD stated during the specimen embedding process, the histotechnologist incorrectly utilized the tamper embedding tool which resulted in the cross contamination of paraffin embedded blocks. This resulted in an incorrect diagnosis of histopathology slides for Patient #1 (P1). b) P1 had 2 samples: one endocervical currettings and one endometrial currettings. Both samples were positive with high grade serous carcinoma and follow-up immunohistochemical (IHC) staining revealed tumor was present in all levels. LD consulted with the GYN Pathology Director at Yale University who agreed with the diagnosis. P1 ordering physician was notified of the diagnosis on 12/6/18. c) The error was discovered when Patient #1 had a hysterectomy on 12/28/18 at Yale New Haven Hospital. When the tissue from the hysterectomy was examined, no tumor was identified. Yale reexamined the Bridgeport Hospital original histopathology slides and determined the tumor was present therefore it was either entirely removed when the original specimens were collected or the specimens were mixed up or contaminated. d) Bridgeport hospital ran a proximity report from the CoPath laboratory information system for specimens embedded at the same time on 12/4/18. Another case, Patient #2 (P2), was identified with serous carcinoma. One case separated the carcinomas. P2 case was embedded first. e) The middle case between P1 and P2 was a bladder biopsy (Patient #3) (P3). P3 slide was reexamined and it was determined a small piece of serous CA was present on the periphery of the slide and had no bearing on the final diagnosis for P3. f) Genotyping done on P1's original specimens determined the serous CA was not that of P1 but that of P2. P2's follow-up hysterectomy yielded a diagnosis of serous CA. g) When it was determined specimens were contaminated, Bridgeport Hospital processing was stopped on 1/11/19. h) Root Cause Analysis was begun on 1/16/19 and it was determined the tamper used at embedding is the most likely cause of the cross contamination. 2. Record review of the 'Policy for Maintaining Specimen Identity' procedure on 1/28/19 revealed the policy did not address the use of tissue tampers. 3. Record review of the 'Embedding - Routine Embedding' procedure on 1/22/19 revealed the procedure for proper use and cleaning of tissue tampers between specimens was not addressed. 4. Staff interview with histotechnologist #1 (HT1) on 1/24/19 at 1:30 PM revealed: a) HT1 stated he/she embedded the specimens that were cross contaminated. b) HT1 stated tampers are kept on the heating block/plate. If a tamper is used, it is placed on top of the specimen in the paraffin mold, then removed and placed back on the heating plate to melt the paraffin away and the bottom is wiped with a Kimwipe between specimens. Sometimes an embedder may need to press down to get the specimen on the same plane when using a tamper. c) HT1 stated what may have happened that day was possibly some of the prior patient's specimen when pressing down went up the side of the tamper and only the specimen on the bottom came off when wiping. Residual specimen was then carried over to the next two patients. 5. The laboratory processes 49,491 histopathology specimens annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish and follow policies and procedures for an ongoing mechanism to monitor for cross -- 2 of 12 -- contamination in tissue specimen processing and assure that the appropriate diagnosis is issued on the appropriate patient in the subspecialty of histopathology. Findings include: 1. Staff interview with the laboratory director (LD) on 1/22/19 at 9:56 AM revealed, 2 of 2 patients had their tissue blocks cross contaminated during the tissue embedding process on 12/4/18. LD stated during the specimen embedding process, the histotechnologist incorrectly utilized the tamper embedding tool which resulted in the cross contamination of the paraffin embedded blocks. This resulted in an incorrect diagnosis of high grade serous carcinoma. 2. Record review of the 'Policy for Maintaining Specimen Identity' procedure on 1/28/19 revealed the policy did not address the use of tissue tampers. 3. Record review of the 'Embedding - Routine Embedding' procedure on 1/22/19 revealed the procedure for proper use and cleaning of tissue tampers between specimens was not addressed. 4. Record review on 1/23/19 of the Pathology Department Quality Assurance (QA) Log for floater issues revealed: a) Four cases were reported between 6/17/16 and 8/18/17. b) Floaters were not documented from 8/19/17 to 1/23/19. 5. Staff interview with the histology section superviosr #1 on 1/22/19 at 10:23 AM stated pathologists do not routinely report in a QA back to histology staff when they see floaters. 6. Staff interview with the histopathology technical supervisor on 1/23/19 at 10:30 AM stated the process used at Bridgeport Hospital for floaters is to send the histology general supervisor an email with the information for investigation and documentation. 7. The laboratory processes 49,491 histopathology specimens annually. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of laboratory policies and procedures and interviews it was determined that the laboratory failed to maintain quality control material for at least two years. Findings include: 1. The laboratory procedure titled QUALITY CONTROL EVALUATION OF THE STAIN AND SLIDE PREPARATION stated that a buccal smear was run each day on the automatic stainer to evaluate the quality and stain characteristics of the Papanicolaou stain. a. The Survey Team requested and the laboratory failed to provide any of the stained buccal smear slides, used to assess the quality and characteristics of the Papanicolaou stain, prior to 8/28/18. 2. During an interview on 9/11/18 at 8:30 AM Cytotechnologist #2 stated that the stained buccal smear slides were discarded after two to three weeks. 3. These findings were reviewed with and confirmed by the Laboratory Director/Technical Supervisor #1, Technical Supervisor #2, and Technical Supervisor #3 during an interview on 9/11/18 at 4:30 PM. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This CONDITION is not met as evidenced by: Based on the review of written procedures, record review, surveyor interviews, and observation the laboratory failed to ensure that rapid stain effusion slides were maintained and available for review (refer to D5203); failed to follow written procedures for processing urine and effusion specimens (refer to D5401); failed to establish written procedures for the rapid stain assessment, the non-gynecologic Papanicolaou stain assessment, and safety cabinet maintenance (refer to D5403); failed to ensure that two of five pathologists had Becton Dickinson (BD) SurePath morphology training and failed to follow manufacturer's guidelines for BD SurePath processors (refer to D5411); failed to establish performance specifications when the laboratory modified the BD SurePath test system (refer to D5423); failed to ensure that the required maintenance was performed on the Shandon Cytospin and two Hettich centrifuges (refer to D5429); failed to assess the rapid fine needle aspiration stain and Papanicolaou stain materials each day of use (refer to D5473); failed to follow written procedures to ensure that corrected reports indicated the basis for correction (refer to D5659); and failed to ensure that the corrected report dates were designated on corrected laboratory reports. The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. 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 the review of laboratory policies and procedures and interviews it was determined that the laboratory failed to establish written policies and procedures to ensure that the rapid stain effusion slides were maintained to ensure the optimum integrity of a patient's specimen from collection through reporting of results. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written policy or procedure to ensure that all specimen slides were maintained by the laboratory and available for review. 2. The laboratory procedure titled PROTOCOL FOR SPECIMENS WITH A HIGH POTENTIAL FOR CROSS CONTAMINATION RAPID STAIN -EFFUSION PROTOCOL stated that one slide from each effusion prepared with direct smears would be stained with Methylene Blue to assess for cellularity or malignancy. The procedure did not designate that the Methylene Blue slides would be maintained and stored to ensure the optimum integrity of a patient's specimen. 3. The Survey Team reviewed one cytology fluid report (NB18-51) and corresponding slides. The report stated that the specimen had a rapid stain slide, two Papanicolaou stained slides, and one cell block slide. a. The laboratory failed to provide one of four slides. The rapid stain slide was not available for review. 4. Cytotechnologist #2 stated during an interview on 9/11/18 at 8:25 AM the the rapid stain slides were only maintained for two to three weeks. The slides were kept on a 20 slide storage tray and when the tray was full, the slides were discarded. 5. These findings were reviewed with and confirmed by the Laboratory Director/Technical Supervisor #1, Technical Supervisor #2, and Technical Supervisor #3 during an interview on 9/11/18 at 4:30 PM. -- 2 of 12 -- 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 the review of eighty laboratory policies and procedures, observation, and interview it was determined that the laboratory failed to follow written procedures for two laboratory processes. Findings include: 1. The laboratory failed to follow the written procedure titled NON-GYN PROCESSING OUTLINE which stated that two direct smears or four cytospins were made on urine cytology specimens. a. On 9/10/18 at 10:15 AM the Survey Team observed Cytopreparatory Technician #1 process seven urine cytology specimens. The specimens were processed with the BD SurePath technique. Direct smears or cytospin slides were not prepared. Specimens include: - NB18-1749 -NB18-1750 -NB18-1751 -NB18-1752 -NB18-1753 -NB18-1754 -NB18- 1755 2. The laboratory failed to follow the written procedure titled PROTOCOL FOR DIRECT SMEARS which stated that two direct smears were made on effusion specimens when there was sufficient cellular material. a. During an interview on 9/11 /18 at 12:45 PM Cytotechnologist #2 stated that four smears were made on effusion specimens with sufficient cellular material. 3. These findings were reviewed with and confirmed by the Laboratory Director/Technical Supervisor #1, Technical Supervisor #2, and Technical Supervisor #3 during an interview on 9/13/18 at 1:00 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)

Summary Statement of Deficiencies D0000 An on-site complaint investigation of the Bridgeport Hospital Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 surveyor observation, record review and staff interview, the cytology laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results. Refer to D5203, D5209, D5311, D5313, D5393, D5403, D5407, D5411, and D5821. 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 record review and staff interview, the laboratory failed to establish and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- follow written policies and procedures to ensure positive identification and correct orientation of specimens and slides while utilizing the SurePath liquid based technology in the subspecialty of cytology. Findings include: 1. Staff interview with pathologist #2 (P2) on 7/3/18 at 10:17 AM revealed, a) 8 of 12 patients had their slides switched with each other during slide preparation. P2 stated during specimen processing and slide preparation, the cytology prep technician loaded the slides incorrectly which resulted in the switching of 8 samples. This resulted in an incorrect positive GYN smear for Patient #1 and an incorrect negative urine cytology result for Patient #2. b) Urine and PAPs were switched because the tray was loaded backwards. c)