Physicians Stat Lab Inc

Summary Statement of Deficiencies D0000 An unannounced CLIA complaint survey was conducted at Physicians Stat Lab from 06/09/2024 to 08/12/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D3000 - Facility Adminstration 493.1100 D5200 - General Laboratory Systems 493.1230 D5300 - Preanalytic Systems 493.1240 D5400 - Analytic Systems 493.1250 D5800 - Postanalytic Systems 493.1290 D6000 - Moderate Complexity Laboratory Director 493.1403 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to have available, patient records and instrument printouts from January 2022 to 9/27/2023 (See D3031) and the laboratory failed to retain proficiency testing records for 2023 and 2024 (See D3037). D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(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 15 -- 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 observation, record review and interview, the laboratory failed to have patient records and instrument printouts available from January 2022 to 9/27/2023. Findings Included: On 6/27/2024 at 11:01 AM, tour of the lab revealed Alinity ci- series and Cell Dyn Ruby in use for Chemistry and Hematology testing. Cell Dyn Ruby had access to Hematology results from 9/28/2023 to 6/19/2024. Cell Dyn Ruby did not store any Hematology instrument results from 1/1 /2022 to 9/27/2023. Alinity ci-series had access to Chemistry results from 9/28/2023 to 6/19/2024. Alinity ci- series did not have any stored Chemistry results from 1/1/ 2022 to 2/9/2023. On 6/24 /2024 at 11:08 AM, the Administration Assistant stated the laboratory had changed their laboratory management system form Avalon to Osmeir. They stated it was not possible to gain access to Avalon records. The patient information records from 1/1 /2022 to 1/1/2024 could not be pulled in Avalon system. Review of record retention policy effective date 6/10/2020 read "testing record: 1. Instrument printouts (not interfaced/LIS) and worksheets Retention period 2 years. 2. Patient results and reports, including original and corrected reports and referral laboratory reports Retention period 2 years." On 6/27/2024 at 11:01 AM, the Technologist stated older instrument data could not be pulled form Cell Dyn Ruby and Alinity ci-series. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing (PT) records, and interview, the laboratory failed to retain proficiency testing records for 2023 and 2024. Findings Included: The laboratory used API for PT in 2023. Review of the API 2023 Chemistry - Core Remedial PT revealed the instrument printouts were missing Review of the API 2023 Chemistry - Core PT 2nd event revealed the instrument printouts were missing. Review of the API 2023 Chemistry - Miscellaneous PT 1st event revealed the instrument printouts for microalbumin, sex hormone binding globulin, testosterone (free) and testosterone (total) were missing. Review of the API 2023 Chemistry - Miscellaneous PT 2nd event revealed the instrument printouts for microalbumin, sex hormone binding globulin, testosterone (free) and testosterone (total) were missing. Review of the API 2023 Hematology / Coagulation PT 1st event revealed the instrument printouts were missing for hematology testing. Review of the API 2023 Hematology / Coagulation PT 2nd event revealed the instrument printouts were missing for hematology and urinalysis testing. Review of the API 2023 Immunology / Immunohematology PT 1st event and the 3rd events revealed the instrument printouts were missing. The laboratory used CAP for PT in 2024 Review of the CAP 2024 Hemoglobin A1c PT 1st event revealed the instrument printings were missing. Review of the CAP 2024 Diagnostic Immunology PT 1st event revealed the instrument printouts were missing. On 06/27/24 at 11:38 AM, Testing Person A acknowledged the instrument printouts were missing. -- 2 of 15 -- D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, review of records and procedures, and interview, the laboratory failed to ensure confidentiality of patient information from August 23, 2023 to June 19, 2024 (See D5201), and the laboratory failed to follow written policies and procedures that ensured 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. (See D5203). 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. This STANDARD is not met as evidenced by: Based on observation, review of building floor plan and the laboratory's lease agreement, and interview, the laboratory failed to ensure confidentiality of patient information from August 23, 2023 to June 19, 2024. The laboratory failed to prevent the sharing of passwords for office staff and access to a referral laboratory's laboratory management system (LIS) which exposed patient information and test results to any staff member in the office or laboratory. Findings Included: On 06/19/2024 at 3:30 PM, a room next to the laboratory was found to have a broken door frame and the door would not remain closed. Observation of Suite 201 revealed the room was used for histopathology testing and currently used for storage. Review of the building floor plan showed the room was accessible to anyone entering the second floor of the building. Review of the Lease Agreement noted the suites numbers leased to the tenant (laboratory) and a diagram of the space leased (Exhibit B) in the Lease Agreement was signed and dated by a representative of the tenant on 08/23/2023. The Lease Agreement stated the "Landlord, subject to the terms hereof and in consideration of the obligations and conditions set forth hereafter, does hereby lease to Tenant; and Tenant, in consideration of those obligations and conditions, does hereby lease from Landlord the property located at Suite 201/ Smart Space 8, Suite 204, Suite 205. and Suite 206, . . ." Review of the Lease Agreement Exhibit B showed diagram of the lay out of the second floor and which suites were included in the Lease Agreement. Examination of the room revealed the room contained 30 plastic containers with the laboratory's patient requisitions, 176 boxes of patient tissue blocks, and 52 boxes of histology slides. Review of the contents of the black containers revealed the containers were filled with the laboratory's patient requisitions. The patients' requisitions listed patients' names, dates of birth, addresses, phone numbers, diagnosis or diagnosis code, Medicaid/Medicare numbers, social security numbers, and copies of drivers licenses. The histology slides and tissue -- 3 of 15 -- blocks were labeled with patients' names and/or case numbers. There was one patient consult report on a counter which included the name, date of birth and diagnosis of the patient. On 06/25/2024 at 11:50 AM, the Administrator stated the door broke sometime in July or August 2023. On 06/19/2024 at 6:00 PM, Suite 201 was secured so that no one could enter the room through that door. On 6/21/2024 at 4:57 PM, tour of the lab revealed the Technologist, Administration Assistant, Lab Assistant and Operations Manager's passwords were stored in all laboratory computers and anyone had access to it. The Operations Manager, Administration Assistant and Lab Assistant had access to change patient results in laboratory management system. The Operations Manager and Administration Assistant had access to one for their referral laboratory's Osmeir laboratory management system. The Operations Manager and Administration Assistant could accession, see patient results, patient demographics for anyone tested in referral laboratory's LIS system. Review of LIS policy revealed no policy for shared passwords and access to referral laboratory's LIS to protect patient information. On 6/24/2024 at 11:32 AM, the Administration Assistant and Lab Assistant confirmed they had access to LIS for referral laboratory and passwords were shared in the laboratory 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 observation, review of the laboratory's procedure manual, review of documents, and interview, it was determined the laboratory failed to follow written policies and procedures that ensured 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. Findings Include: A) Review of the procedure titled, Specimen Collection, Handling, and Transporting approved by the Lab Director 5/24/24 noted the following: 1) specimens must be properly labeled or they will not be processed. Labels should contain patients names and second identifier (date of birth), body source of specimen, date, time collected and initials of collector. 2) reject criteria for coagulation studies, Serology, and Hematology specimens stated reject criteria included aged beyond reliable time limits; for Urinalysis un-refrigerated specimens, Specimens should be refrigerated if not tested with 2 hours of collection. and 3) Specimen Preparation for Transportation read, when appropriate, the specimen is placed into a third rigid container (cooler) which is also a climate controlled environment. This helps to protect the integrity of the specimen until it reached the laboratory. 4) Specimen temporary Storage-specimens shall be stored for a specified time, and at conditions that ensure stability of sample properties. 4) handwritten labels (salvageable) missing date and time of collection. On 6/24/24 at the clinical lab at 11: 45 AM, Testing Personnel A and Accessioner A stated they were not aware of written instructions for handling of patient samples for the laboratory or for Reference Lab A for patient samples to ensure positive identification and integrity was maintained. B) At the off site Draw Station, a plastic bin with three urine samples in cups was observed on 6/24/24 at 8:17 AM. The bin had a sign instructing for drop off only and to label with FULL name and birth date. Draw Station phlebotomist A stated on 6/24 /24 at 8:30 AM, the patient urine samples in the bin were dropped off from patients -- 4 of 15 -- who had not been able to provide a urine sample at the time of blood draw. The phlebotomist A confirmed there were no written directions provided to patients on how to properly collect and store samples until dropped off at the lab. The phlebotomist A confirmed there was no way to know date, time, and storage of samples collected by patients prior to drop off at the draw station. There was no client service manual or any specific written instructions provided for review for collection, processing, storage, and transport of patient samples while at the draw station and transport from the lab draw station. confirmed on 06/24/24 at 08:17 AM and 07/05/24 at 10:30 AM there was be no client service manual or any specific written instructions provided to staff for collection, processing, storage, and transport of patient samples for the lab or reference lab A. On 7/5/24 at 10:15 AM, phlebotomist A said Accessioner A from the main lab verbally instructed the draw station staff to hold patient samples from 7/3/24 until 7/5/24. Phlebotomist A stated samples would be shipped to Reference Lab A via transport company at 1:00 PM and that all patient samples from 7/03/24 and 7/05/24 would be put in one box with no ice pack. The transport label for the patient sample box address was not the address of Reference Lab A. On 06/24/24 at 8:20 AM, and 7/5/24 at 10:20 AM, the patient sample storage refrigerator/freezer did not have a thermometer to monitor the temperature of the refrigerator or the freezer compartment, the two centrifuges were pre-set for time and speed (unknown what settings were). On 06/24/24 at 8:20 AM, and 07/05/24 at 10:30 AM, phlebotomist A stated there was no monitoring of temperatures of the refrigerator /freezer or the room temperatures to ensure integrity of patient samples and the temperature requirements were not known to the staff. On 06/24/24 at 8:20 AM, phlebotomist A there was no way to adjust the time and speed of centrifuges for specific test requirements and did not know what the required time and speed setting of the centrifuges should be. On 7/5/24 at 10:40 AM, the following patient samples were observed in the laboratory refrigerator in a transport bag: 15 serum separator tubes (SST), 11 lavender top vaccutainers tubes, 2 blue top vaccutainers tubes, 3 red top vaccutainers tubes, 2 green top vaccutainers tubes, and 3 urinalysis cups. On 7/5 /24 at 10:40 AM, phlebotomist A said the samples in the transport bag were all the patient samples from 7/3/24 and were listed on the Laboratory Specimen Log. Review of the Laboratory Specimen Log dated 7/3/24 documented the date, time received, patient name, under test ordered the type of collection tube or if urine, and initials. The Laboratory Specimen Log for 7/3/24 did not include one of the patient urine samples, which was confirmed by phlebotomist A on 7/5/24 at 10:40 AM. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to have established and followed written policies and procedures for specimen storage and preservation, conditions for specimen transportation, specimen acceptability and rejection, and specimen referral, (See D5311). -- 5 of 15 -- 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 observation, record review, and interview, it was determined the laboratory failed to have established and followed written policies and procedures for specimen storage and preservation, conditions for specimen transportation, specimen acceptability and rejection, and specimen referral. Findings Included: Review of the policy titled, Specimen Collection Handling and Transporting reviewed and approved by the Lab Director on 05/24/2024 showed rejection criteria for Hematology Test. The policy included if specimens aged beyond reliable time limits and specimens not meeting stability chart, for Coagulation Studies if specimens aged beyond reliable time limits, and for Urinalysis un-refrigerated specimens if not tested within 2 hours. The policy did not indicate what the aged beyond time limits were for Hematology and Coagulation, what the stability chart limits were, and what the temperature limits for refrigerated specimens were for storage. Review of Reference Lab #A's document titled Sample Collection Requirement, provided to surveyors as client instructions for referral of laboratory samples, noted for Coagulation, submit frozen citrated plasma if storage exceeds 24 hours and under storage requirements to be refrigerated, and for Hematology and Urinalysis specimen storage requirements were to be refrigerated. There was no written instructions provided if there were any time limits for Hematology, Coagulation or Urinalysis specimens, if specimens required centrifugation, what speed and time was required for specimen processing, what was acceptable temperature limits for refrigerated and frozen specimens were. On 6/24/24 at the clinical lab at 11:45 AM, Testing Personnel A and Accessioner A stated they were not aware of written instructions for handling of patient samples for the laboratory or for Reference Lab A for patient samples to ensure positive identification and integrity was maintained including specimen storage and preservation, conditions for specimen transportation, specimen acceptability and rejection, and specimen referral. On 06/24/24 at 8:20 AM, and 7/5/24 at 10:20 AM, the patient sample storage refrigerator/freezer did not have a thermometer to monitor the temperature of the refrigerator or the freezer compartment. The two centrifuges were pre-set for time and speed (unknown what settings were). On 06/24/24 at 8:20 AM, and 07/05/24 at 10:30 AM, phlebotomist A said there was no monitoring of temperatures of the refrigerator /freezer or the room temperatures to ensure integrity of patient samples and the temperature requirements were not known to the staff. Phlebotomist A confirmed on 06/24/24 at 8:20 AM, there was no way to adjust the time and speed of centrifuges for specific test requirements and the phlebotomist did not know what the required time and speed setting of the centrifuges should be. On 7/5/24 at 10:40 AM, the following patient samples were observed in the laboratory refrigerator in a transport bag: 15 serum separator tubes (SST), 11 lavender top vacutainer tubes for Hematology testing, 2 blue top vaccutainers tubes for Coagulation testing , 3 red top vaccutainers tubes, 2 green top vaccutainers tubes, and 3 urinalysis cups. On 7/5/24 at 10:40 AM, phlebotomist A stated the samples in the transport bag were all the patient samples from 7/3/24 and were listed on the Laboratory Specimen Log. The specimens were to -- 6 of 15 -- be referred to Reference Lab A. Review of the Laboratory Specimen Log dated 7/3/24 documented the date, time received, patient name, under test ordered the type of collection tube or if urine, and initials. There was no indication of the Coagulation specimens older than 24 hours had been or would be frozen during storage and transport as required by the Sample Collection Requirement, provided as client instructions for referral of laboratory samples provided to the surveyors. There was no process or mechanism to transport specimens to the clinical lab or referral lab per the indicated temperature requirements for refrigerator or frozen. On 06/24/24 at 8:20 AM, and 07/05/24 at 10:30 AM, phlebotomist A said there was no process or mechanism to transport specimens to the clinical lab or referral lab refrigerated or frozen, all samples put together in a bag/box for transport. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on document review, and interview, the laboratory failed to run hepatitis C virus (Anti- HCV), hepatitis B(HbsAg), Antibody to Hepatitis A Virus, IgM (HAV- IgM) and homocysteine test (Homc-undil) with unexpired reagents before patient testing (See D5417), the laboratory failed to demonstrate accuracy prior to reporting patient test results for Hematology testing on the Cell Dyn Ruby instrument before reporting patient test results (See D5421), the laboratory failed to run positive and negative controls for the following analytes: TPO antibodies (Anti-TPO), thyroxine test (Free T4) and Folate before patient testing (See D5449), the laboratory failed to document all