Summary:
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, record review, observation and interviews it was determined that Facility A (CLIA #45D1062976) failed to ensure records were maintained of the number of slides prepared for cytology cases (refer to D5203); failed to establish written policies and procedures to assess competency of two of two Cytotechnologists performing cytology processing (refer to D5209); failed to establish written policies and procedures for eight laboratory processes (refer to D5403); failed to follow written policies and procedures for the evaluation and comparison of six of six laboratory statistics, and failed to document six of six required annual statistics for 2016 and 2017 (refer to D5629); failed to establish written policies and procedures for establishing workload limits, reassessing workload limits, prorating workload limits and maintaining workload slides and hours (refer to D5633, D5635, D5637, D5641, D5645); failed to establish written policies and procedures to ensure that corrected reports indicated the basis for the correction on the report (refer to D5659); and failed to ensure that final test reports indicated the name and address of the laboratory location where the test was performed (refer to D5805). 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 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 review of laboratory policies and procedures, laboratory records, glass slide preparations and interviews it was determined that Facility A failed to establish written policies and procedures to ensure records were maintained to document the number of slides prepared for 63 of 63 cases from 2018. Findings include: 1. The Survey Team requested and Facility A failed to provide written policies and procedures to describe how Facility A documented the number of slides prepared for each case. 2. The Survey team reviewed 63 final test reports and the corresponding glass slides. Facility A failed to provide a record of the number of specimen slides prepared for 63 of 63 cases. Cases include: - DC18-57 - DC18-154 - DC18-277 - DC18-279 - DC18-313 - DC18-317 - DC18-344 - DC18-345 - DC18-346 - DC18-347 - DC18-348 - DC18-349 - DC18-350 - DC18-351 - DC18-352 - DC18-353 - DC18- 354 - DC18-355 - DC18-356 - DC18-357 - DC18-358 - DC18-359 - DC18-360 - DC18-361 - DC18-362 - DC18-363 - DC18-364 - DC18-365 - DC18-366 - DC18-367 - DC18-368 - DC18-369 - DC18-370 - DC18-371 - DC18-379 - DC18-386 - DC18- 387 - DC18-388 - DC18-389 - DC18-390 - DC18-391 - DC18-392 - DC18-393 - DC18-394 - DC18-395 - DC18-396 - DC18-397 - DC18-398 - DC18-400 - DC18-401 - DC18-402 - DC18-403 - DC18-404 - DC18-405 - DC18-406 - DC18-407 - DC18- 408 - DC18-409 - DC18-410 - DC18-411 - DC18-412 - DC18-413 - DC18-566 3. During an interview on October 16, 2018 at 3:20 PM, the Anatomic Pathology Manager stated that the number of glass slides was supposed to be documented on the final test reports in the gross description of the specimen. 4. During an interview on October 17, 2018 at 1:00 PM, the Laboratory Director/Technical Supervisor A confirmed that Facility A failed to document the number of slides prepared for each specimen. 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 polices and procedures and interview it was determined that Facility A failed to establish written policies and procedures to assess the competency of two of two Cytotechnologists performing cytology processing. Findings include: 1. The Survey Team requested and Facility A failed to provide written policies and procedures to describe Facility A's process for assessing the competency of the two Cytotechnologists performing cytology processing. Cytotechnologists include: - Cytotechnologist A - Cytotechnologist B 2. During an interview on October 16, 2018 at 2:05 PM, the Laboratory Director/Technical Supervisor A confirmed these findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) -- 2 of 10 -- 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, glass slide preparations and interviews it was determined that Facility A failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. Cross refer to D5203, D5209 Findings include: 1. The Survey Team requested and Facility A failed to provide written policies and procedures for an ongoing mechanism to monitor and assess the quality of the general laboratory system. 2. During an interview on October 17, 2018 at 10:45 AM, the Survey Team asked the Laboratory Director/Technical Supervisor A if there was a mechanism to monitor the general laboratory system of Facility A. The Laboratory Director/Technical Supervisor A stated that Facility A performed a quality assessment review of cases but only looked at "diagnostics, demographics, and billing." a. Facility A failed to establish an ongoing mechanism to ensure records were kept to document the number of slides prepared for each specimen and to establish written policies and procedures to assess the competency of personnel performing cytology processing. 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)