Protzel Pathology Laboratory

Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on observation and interviews with Office Manager and Intake and Reporting Specialist the laboratory failed to ensure cytology specimen slides and laboratory records from 2018 through the date of the survey in 2022 were maintained and stored in a secure area. Findings include: 1. On November 14, 2022 at 9:30 AM, the Office Manager was observed arriving at the facility carrying a cardboard box with cytology specimen slides and patient records. a. During an interview on November 14, 2022 at 9:45 AM, the Office Manager stated that all known cytology specimen slides and corresponding patient records had been kept at the Laboratory Director/Technical Supervisor's place of residence since the initial survey in April 2022. Specimen slides and patient records include: -Cytology specimen slides from 2018, 2019, 2020, 2021 and 2022; -Copies of final cytology test reports for cytology cases from 2018, 2019, 2020, 2021 and 2022; -Copies of corresponding test requisitions. b. The Office Manager confirmed that there was no record in the facility of what had been removed to the Laboratory Director/Technical Supervisor's residence. 2. On November 14, 2022 at 2:15 PM, the Survey Team observed specimen slides and patient records not maintained. Slide folders, plastic containers and mail envelopes were not organized and were scattered in piles on shelves and counters. As the identification of slides and records could not occur while enclosed in their containers and envelopes, a random selection of a few revealed: a. Some envelopes had been stored unopened so contents were not retrieved and properly stored. One sealed envelope was opened in the presence of Intake and Reporting Specialist and included a specimen paraffin block and corresponding patient records that were returned to the facility on an unknown date. b. Some slide folders and containers, which were opened in presence of Intake 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 -- and Reporting Specialist, included specimen slides dating back to 2017. c. Intake and Reporting Specialist and Secretary/Office Assistant stated it was Couriers job to file and it hadn't been done in some time. d. Intake and Reporting Specialist and Office Manager were unable to tell the Survey Team how many cytology slides or cytology cell blocks were in the piles on the shelves. e. Intake and Reporting Specialist confirmed the only cytology specimens that were located and identified with certainty and maintained for retrievability by staff were the cytology specimens that were randomly identified by the Survey Team during the initial visit on April 6, 2022 and the three specimens received since that date. 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 lack of a written cytology policy and procedure manual and interviews a written procedures manual for all cytology tests and examinations performed by the laboratory was not available to laboratory personnel. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written policy and procedure manual for all cytology tests and examinations performed by the laboratory. 2. During an interview on November 14, 2022 at 10:05 AM the Office Manager provided a manual that was brought into the laboratory during the survey. a. The Office Manager stated that the manual "was the old one" and "had been retrieved from the private residence of the Laboratory Director/Technical Supervisor." b. When asked if any of the newly implemented and approved policies and procedures were in the old manual, the Office Manager replied, "I don't think so, it's not updated with anything current, but it is now all online." c. The Survey Team requested that the current online policy and procedures manual be retrieved. The Office Manager replied, "I do not know how to do that. We don't use the computer here and I have no way to retrieve anything until the Intake and Reporting Specialist arrives with his computer." 3. During an interview on November 14, 2022 at 10:35 AM the Survey Team requested of the Intake and Reporting Specialist to retrieve the current policy and procedures manual. The Intake and Reporting Specialist stated that the laboratory's allegation of compliance responses could be retrieved but there was not a policy and procedures manual. 4. During an interview on November 15, 2022 at 9:00 AM the Intake and Reporting Specialist confirmed that the laboratory failed to have a written cytology policy and procedures manual. The Intake and Reporting Specialist stated that the difference between the allegation of compliance responses and a policy and procedure manual was not known but was now understood and it could be developed. 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 -- 2 of 3 -- 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 observation, review of the laboratory's allegation of compliance documents received on 5/5/2022, 6/7/2022 and 7/5/2022, interviews with the Office Manager and Intake and Reporting Specialist and lack of a policy and procedure manual the Laboratory Director failed to be responsible for the overall operation and administration of the laboratory and for assuring compliance with applicable regulations. Cross refer to D3011, D3013, D5201 and D5401 Findings include: 1. The Laboratory Director failed to be responsible for ensuring the necessary precautions for safety from physical, chemical and biohazardous materials. See D3011 2. The Laboratory Director failed to be responsible for the maintenance, retrievability and storage of cytology specimen slides in a secure area. See D3013 3. The Laboratory Director failed to be responsible for ensuring the confidentiality of patient information. See D5201 4. The Laboratory Director failed to be responsible for ensuring a written policy and procedures manual for all cytology tests and examinations performed by the laboratory was accessible and available onsite to all laboratory personnel. See D5401 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 the lack of a policy and procedure manual and interviews the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Cross refer to D5401 1. The Laboratory Director failed to ensure an approved procedures manual was available to all personnel. -- 3 of 3 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. 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 safety procedures to ensure protection from physical, chemical and electrical hazards, and necessary precautions to ensure safety from biohazardous materials. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure protection from physical, chemical and electrical hazards. 2. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure precautions were taken during the handling of biohazardous cytology materials. 3. During an interview on April 4, 2022 at 11:30 AM, the Office Manager and Laboratory Director/Technical Supervisor confirmed these findings. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, cytology specimen slides 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 16 -- corresponding final cytology test reports and interview it was determined that the laboratory failed to establish written policies and procedures to retain copies of all cytology test reports for at least ten years after the date of reporting. The laboratory failed to retain a copy of six of 51 final cytology test reports from 2018 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 for the laboratory's process of retaining copies of all final cytology test reports for at least ten years after the date of reporting. 2. During a review of cytology specimen slides and the corresponding final test reports, the Survey Team requested and the laboratory failed to provide six of 51 final cytology test reports. Final Test Reports include: -RP-981-18 -RP-981A-18 -RP-981B-18 -RP-981C-18 -RP-981D-18 -RP-981E-18 3. During an interview on April 5, 2022 at 11:00 AM, the Office Manager confirmed these findings and stated: "We don't have a computer to search for anything before 2019. I can't find the reports if they're not put back. Sometimes we pull a report out and just don't file it back." 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, cytology specimen slides and interviews it was determined that the laboratory failed to establish written policies and procedures for two laboratory test processes (refer to D5403); failed to establish written policies and procedures for the evaluation of three of three annual statistics (refer to D5629); failed to establish written policies and procedures for the establishment of individual workload limits, and failed to reassess workload limits at least every six months (refer to D5633 and D5637); failed to establish written policies and procedures to ensure that workload limits would be prorated when examining slides in less than eight hours (refer to D5641); failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of slides examined per 24-hour period, and maintain records of the total number of hours spent examining slides per 24-hour period (refer to D5645); failed to establish written policies and procedures to document the workload limit (refer to D5647); failed to establish written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results (refer to D5657); failed to establish written policies and procedures to ensure corrected reports indicated the basis for the correction on the final cytology test report (refer to D5659); and failed to maintain a record system for positive patient identification and the date of specimen receipt (refer to D5787). D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. -- 2 of 16 -- 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 ensure confidentiality of patient information. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the laboratory would ensure confidentiality of patient information. 2. During an interview on April 4, 2022 at 11:30 AM, the Office Manager and Laboratory Director /Technical Supervisor confirmed these findings. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: 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 for the documentation of complaints and problems reported to the laboratory for 2020, 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 for investigating and documenting complaints and problems reported to the laboratory. 2. The Survey Team requested and the laboratory failed to provide documentation of complaints and problems reported to the laboratory. 3. During an interview on April 5, 2022 at 8:45 AM, the Office Manager and the Laboratory Director/Technical Supervisor 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 and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: 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 the Laboratory Director/Technical Supervisor. The laboratory failed to assess the competency of the one of one Laboratory Director /Technical Supervisor in 2020, 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 describe the process to assess the competency of the Laboratory Director/Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for the one of one Laboratory Director/Technical Supervisor during 2020, 2021 and to the date of the survey in 2022. Laboratory Director/Technical Supervisor Includes: -Laboratory Director/Technical Supervisor 3. During an interview on April 4, 2022 at 11:30 AM, the Office Manager and Laboratory Director/Technical Supervisor confirmed these findings. -- 3 of 16 -- D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, cytology specimen slides and interviews it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. The laboratory failed to document general laboratory quality assessment activities during 2020, 2021 and to the date of the survey in 2022. Cross refer to D5201, D5205 and D5209 Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the general laboratory systems. 2. The Survey Team requested and the laboratory failed to provide documentation of general laboratory quality assessment activities during 2020, 2021 and to the date of the survey in 2022. a. The laboratory failed to document a system for monitoring and evaluating confidentiality of patient information. (See D5201) b. The laboratory failed to document a system for monitoring and evaluating complaints and problems reported to the laboratory. (See D5205) c. The laboratory failed to document a system for monitoring and evaluating the competency of the Laboratory Director/Technical Supervisor. (See D5209) 3. The laboratory failed to document a system for monitoring and evaluating the completeness of specimen requisitions. a. Four of 44 patient specimen requisitions from 2018 to the date of the survey failed to include the date of specimen collection. Patient Specimen Requisitions include: -RP-2244-19 -RP-2723-21 -RP-0041-22 -RP- 0448-22 b. Three of 44 patient specimen requisitions from 2018 to the date of the survey failed to include the specimen source. Patient Specimen Requisitions include: - RP-1194-18 -RP-1467-18 -RP-0690-19 4. During interviews on April 5, 2022 at 8:20 AM and 8:45 AM, the Office Manager and Laboratory Director/Technical Supervisor confirmed these findings. 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 laboratory records it was determined that the laboratory failed to ensure that patient specimen information was transcribed accurately into the final cytology test report for five of 44 specimens sampled from 2018 to the date of the survey in 2022. Findings include: 1. The Survey Team reviewed 44 final cytology test reports with the corresponding laboratory records. a. Five of 44 final cytology test reports failed to have accurate patient specimen information transcribed into the final cytology test report. Patient Specimens include: -RP-1996-19 Test Report Information: Date Collected 8-21-19 Specimen Requisition Information: Date -- 4 of 16 -- Collected 8-2-19 Test Report Information: First Name "Barora" Specimen Requisition Information: First Name "Barbora" -RP-0041-22 Test Report Information: First Name "Phillip" Specimen Requisition Information: First Name "Philipp" -RP-2059-18 Test Report Description: Interpretation states "Papanicolaou stained smears and cell block sections prepared from left breast seroma fluid are bright. "Bright" is a data entry error and the intended diagnostic description is unknown. Specimen Requisition Information: "Bright" is not documented. -RP-2588-18 Test Report Information: Date Collected 10-30-2018 and Date Received 10-03-2018 Specimen Requisition Information: Date Collected 10-30-2018 and Date Received not provided -RP-2799- 18 Test Report Information: Gross Description to include the number of slides was not transcribed 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, interviews and observation of cytology specimen slides it was determined that the laboratory failed to establish written policies and procedures to describe the laboratory's requirements for specimen collection, specimen labeling, specimen storage and preservation, specimen transportation, specimen processing and accessioning, specimen acceptability and rejection and specimen referral. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's requirements for the following: -specimen collection -specimen labeling - specimen storage and preservation -specimen transportation -specimen processing and accessioning -specimen acceptability and rejection -specimen referral a. During an interview on April 4, 2022 at 11:30 AM, the Office Manager and Laboratory Director /Technical Supervisor confirmed these findings 2. The laboratory failed to ensure instruction were provided for labeling on 54 of 54 cytology specimen slides from 2018 to the date of the survey in 2022, prior to the application of an assigned accession number. a. The Survey Team observed cytology specimen slides that were received as unlabeled direct smears from physicians offices. b. The cytology specimen slides were assigned an accession number upon receipt and accessioning in the laboratory. The assigned accession number was not on the cytology specimen slides from the time of collection through the preanalytic phase of testing. Specimen Case and # of Slides include: -RP-0509-18 4 slides -RP-0675-18 4 slides -RP-1312-18 2 slides -RP-1467-18 2 slides -RP-2185-18 2 slides -RP-2380-18 2 slides -RP-2716-18 3 slides -RP-0179-19 2 slides -RP-0811-19 2 slides -RP-0889-19 4 slides -RP-0890- 19 4 slides -RP-1906-19 2 slides -RP-0139-21 1 slide -RP-0624-20 2 slides -RP-0714- 21 2 slides -RP-0726-20 6 slides -RP-0851-21 2 slides -RP-2723-21 4 slides -RP- 2933-21 2 slides -RP-0041-22 2 slides 3. During an interview on April 4, 2022 at 2:30 PM, when asked how the cytology specimen slides were labeled prior to being assigned the accession number, the Office Manager replied: -"They get the number when they come in and before we send them out. The offices send a paper request slip with them so we know." When asked if the laboratory provided instructions or -- 5 of 16 -- required a patient name or other identifier to be written on the slide, the Office Manager replied that the laboratory assigns the next accession number. The Office Manager confirmed that the cytology specimen slides failed to include a patient name or any other unique identifier prior to the assignment of the accession number. 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 review of laboratory policies and procedures, laboratory records, cytology specimen slides and interviews it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic systems. The laboratory failed to document preanalytic quality assessment activities during 2020, 2021 and to the date of the survey in 2022. Cross refer to D5309 and D5311 Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the preanalytic laboratory systems. 2. The Survey Team requested and the laboratory failed to provide documentation of preanalytic laboratory quality assessment activities during 2020, 2021 and to the date of the survey in 2022. a. The laboratory failed to have an ongoing mechanism to ensure the accuracy of transcription from patient records to the final cytology test report. (See D5309) b. The laboratory failed to have an ongoing mechanism to identify problems with specimen collection, specimen labeling, specimen storage and preservation, specimen transportation, specimen processing and accessioning, specimen acceptability and specimen referral. (See D5311) 3. During an interview on April 5, 2022 at 8:20 AM, the Office Manager and Laboratory Director/Technical Supervisor confirmed these findings. 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 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 the surveyor's review of the laboratory's testing reagent expiration dates, and an interview with laboratory personnel (LP) on 4/8/2021 between 10 a.m and 11:30 a. m., it was determined that one reagent used for tissue staining was expired. Findings include: 1. On 4/8/2021, an inspection was conducted between 10 a.m. and 11:30 a.m. 2. During a review of the reagent expiration dates , it was noted at approximately 10: 30 a.m. that the expiration date on one container of the reagents used in the tissue staining process had expired. The LP recognized that this reagent had indeed expired. This reagent was currently in use for slide preparation and diagnostic evaluation. 3. The reagent that was expired was toluidine blue (used with the Cryostat) and it had expired on 2/1/2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --