Stony Point Surgery Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Stony Point Surgery Center on April 29, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a tour, review of equipment maintenance logs, manufacturer's operations manual, policies, and interviews, the laboratory failed to document performance of required charcoal cartridge filter replacement maintenance according to the fume hood manufacturer's instructions and laboratory policy during the survey timeframe of May 10, 2023 up to the date of the inspection on April 29, 2025. Findings include: 1. During a tour of the histopathology laboratory on 4/29/25, the inspector noted a Southern Air maintenance service sticker on the LABCONCO fume hood dated 7/1 /21. The inspector noted a manufacturer's sticker that instructed "Replacement for this filter is LABCONCO #69007. Your health could be at risk. Replace filter regularly". The inspector inquired regarding the laboratory's policy for the fume hood filter maintenance. The laboratory director (LD) stated that the Materials Manager would be contacted for confirmation regarding the hospital biomedical engineering protocol for the fume hood filter replacement. 2. Review of the laboratory's equipment maintenance logs revealed no fume hood maintenance records. The inspector noted that no filter replacement was documented during the review timeframe of 5/10/23 - 4 /29/25. 3. Review of the LABCONCO Fume Adsorber Operations online manual revealed manufacturer's instructions that stated, "LABCONCO filters need replacement to maintain optimal performance and safety, ensuring proper filtration of 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 -- organic vapors in the laboratory. It is important to include filter replacement in routine preventative maintenance schedule. The carbon filter requires routine monitoring and replacement. Time can be used to anticipate saturation or TWA (recommended Exposure Limits expressed as a Time Weighted Average) levels. However, this does not replace the need for sampling. Consult LABCONCO technical specialist for an estimate of carbon filter lifebased on chemical usage. Analytical instrumentation should always be used to determine concentrations in the carbon filter. The carbon filters must be checked with detector tubes or other means at intervals of 20% of the total estimated filter life. The exception to the 20% recommendation is formaldehyde and any carcinogen or suspected carcinogen. These more hazardous chemicals must be checked at least every 10% of the total estimated time". 4. During the inspection, the LD placed a telephone call to the hospital's Materials Manager and relayed to the inspector on 4/29/25 at 3:30 PM, that the protocol is to replace histopathology fume hood charcoal filters annually. The policy was emailed to the inspector. The protocol (titled: Fume Hood Equipment Service and Maintenance Policy) stated, "Testing and service shall be performed on an annual basis." 5. An interview with the LD on 4/29 /25 at 4:00 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Stony Point Surgery Center on July 8, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F. R. 493-1250 Condition: Analytic Systems. 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 a tour of the testing area, review of manufacturer's operations manual, policy and procedures (P&P), maintenance logs, lack of documentation, patient test logs, and an interview, the laboratory failed to: 1. ensure the monitoring and documentation of room temperatures and relative humidity (Refer to D5413) 2. ensure cyrostat instrument maintenance was performed (Refer to D5429 part A) **REPEAT DEFICIENCY** and 3. ensure the microscope preventative maintenance was performed according to the established policy (Refer to D5429 part B). D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's operations manual, maintenance logs, lack of documentation, patient test logs, and an interview, the laboratory failed to monitor and document the room temperature and relative humidity according to the manufacturer's instructions for the twenty-four (24) months reviewed, performing forty-eight (48) patient tissue samples. Dates of record review 06/01/19 to 6/30/21. Findings include: 1. Review of the Leica CM 1850 Cryostat Operations Manual revealed the following: "4.1 Site Requirements- room temperature max. 35 degrees Celsius, air humidity must not exceed 60%. "Note- high room temperatures and excessive air humidity affect the cooling capacity of the cryostat."" 2. Review of the available maintenance logs revealed lack of documentation of the monitoring of the room temperature and relative humidity for the 24 months reviewed. The inspector requested the aforementioned documentation and it was not available for review. 3. Review of patient test logs revealed 48 patient tissue samples conducted during the timeframe of review. 4. An exit interview with the chief nursing officer on 07/08/21 at 13:30 PM confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** A. Based on a review of the manufacturer's operations manual, policy & procedures (P&P), maintenance and patient test logs, and an interview, the laboratory failed to document performance of daily cryostat instrument maintenance according to the manufacturer's instructions on nine (9) days while processing 16 patient tissue samples during the twenty-four (24) months reviewed. Dates of record review 06/01/19 to 6/30/21. Findings include: 1. Review of the Leica CM 1850 Cryostat Operations Manual revealed Cleaning, Disinfection, Maintenance Instructions in Section 9 that stated: "Perform the cleaning procedures every day: removing frozen section waste from the cryostat with the cold brush every day, remove the section waste, drain the cleaning liquid after cleaning daily, spray disinfection (recommend LEICA Cryofect-note the cryostat has to be disinfected after each daily use)". 2. Review of the P&P (signed by the lab director 05/14/19) revealed the following policy- "Preventative Maintenance and Decontamination of the Crytostat" which stated "Routine disinfection cleaning will be performed as needed/ either on a daily, weekly or monthly schedule based on volume of frozen section cases performed. Once the cryostat is used, the site staff will perform cleaning and maintenance procedures before the next scheduled day of frozen sections". 3. Review of the laboratory's Surgery Center Cryostat Temperature and Maintenance logs and patient test logs revealed no documentation of the required daily maintenance on the -- 2 of 3 -- following days while processing patient tissue samples: 12/11/19- 4 patients, 12/31 /19- 1 patient, 1/15//20- 2 patients, 4/21/20- 2 patients, 8/5/20- 1 patient, 8/12/20- 1 patient, 12/02/20- 1 patient, 12/22/20- 2 patients and 12/29/20- 2 patients. Total 9 days and 16 patients. The inspector requested to review the daily maintenance for the dates of patient testing outlined above. No records were available. 4. An exit interview with the chief nursing officer on 07/08/21 at 13:30 PM confirmed the findings. B. Based on the review of the tour of the testing area, policy & procedures (P&P), and interview, the laboratory failed to follow the established policy for performing the yearly preventative maintenance (PM) for the microscope in the calendar year 2020. Findings include: 1. Tour of the testing area on 07/08/21 at approximately 12:30 PM revealed the lab utilizes the microscope to perform the technical component of histological tissue reviews. 2. Review of the P&P (signed by the lab director 05/14 /19) revealed the following statement: "Preventative Maintenance- The pathology microscope will have yearly PM's performed." The inspector requested to review the microscope PM performed for the calendar year 2020. The documentation was not available for review. 3. An exit interview with the chief nursing officer on 07/08/21 at 13:30 PM confirmed the findings. 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 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 a tour of the testing area, review of manufacturer's operations manual, policy and procedures (P&P), maintenance logs, lack of documentation, patient test logs, and an interview, the laboratory director failed to ensure: 1) the monitoring and documentation of room temperatures and relative humidity (Refer to D5413); 2) the cyrostat instrument maintenance was performed (Refer to D5429 part A); and 3) the microscope preventative maintenance was performed according to the established policy (Refer to D5429 part B). -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Stony Point Surgery Center on April 24, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 procedures, instrument maintenance documentation, and an interview, the laboratory failed to follow the established procedure for cryostat decontamination in calendar year 2018. Findings include: 1. Review of the laboratory's procedures revealed a quality assurance (QA) policy (Decontamination of the Cryostat) that stated "Decontaminate the cryostat twice annually". 2. Review of the laboratory's Leica CM 1850 Cryostat maintenance documentation revealed one (1) decontaminaton procedure documented in calendar year 2018 (recorded on 4/4/18). The inspector requested additional decontamination documentation for 2018. No records were available. 3. In an exit interview with the clinical and medical directors at 12:30 PM, the above listed findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on a review of the manufacturer's operations manual, procedure manual, maintenance and patient test logs, and an interview, the laboratory failed to document performance of daily cryostat instrument maintenance according to the manufacturer's instructions on five (5) days while processing 5 patient tissue cases during the sixteen (16) months reviewed (dates of record review 12/1/17 to 4/24/19). Findings include: 1. Review of the Leica CM 1850 Cryostat Operations Manual revealed Maintenance Instructions in Section 10 that stated: "Perform the cleaning procedures every day: removing frozen section waste from the cryostat with the cold brush every day, remove the section waste, drain the cleaning liquid after cleaning daily, spray disinfection (recommend LEICA Cryofect-note the cryostat has to be disinfected after each daily use)". 2. Review of the laboratory's procedure manual revealed a policy (Preventative Maintenance) that stated "perform routine disinfection cleaning daily following use (typically 1-2 times a week)". 3. Review of the laboratory's Surgery Center Cryostat Temperature and Maintenance logs and patient test logs revealed no documentation of the required daily maintenance on the following 5 days while processing patient tissue case numbers : 07/25/18- DP18-1366 08/29/18- DP18-1440 09/12/18- DP18-1723 12/26/18- DP18-2162 02/27/19- DP19-259 The inspector requested to review the daily maintenance for the dates of patient testing outlined above. No records were available. 4. In an exit interview with the clinical and medical directors at 12:30 PM, the above listed findings were confirmed. B. Based on a review of the manufacturer's operations manual, maintenance and patient logs, and an interview, the laboratory failed to document performance of the cryostat instrument weekly maintenance according to the manufacturer's instructions for fifty-six (56) of sixty-four (64) weeks reviewed while processing one hundred fifty (150) patient tissue cases. Findings include: 1. Review of the Leica CM 1850 Cryostat Operations Manual revealed Maintenance Instructions in Section 10 that stated: "Perform once per week: lubricate the specimen cylinder". 2. Review of the laboratory's Surgery Center Cryostat Temperature and Maintenance monthly maintenance logs revealed cryostat oil (cylinder lubrication) listed as: "perform weekly". During the maintenance and patient test log review, the inspector noted the required weekly maintenance was not documented as performed on fifty-six (56) weeks while 150 patient test cases were processed (review timeframe 12/1/17 to 4/24/19). Additional documentation of the cylinder lubrication maintenance was requested. No records were available. The Clinical Director in an interview at approximately 11:30 AM, stated "Our histotechnician completes the maintenance but it is not always recorded on the logsheet". 3. In an exit interview with the clinical and medical directors at 12:30 PM, the above listed findings were confirmed. C. Based on a review of manufacturer's operations manual, procedure manual, equipment maintenance records, and an interview, the laboratory failed to document the cryostat instrument annual preventative maintenance (PM) procedures according to the manufacturer's instructions in calendar year 2018. Findings include: 1. Review of the Leica CM 1850 Cryostat Operations Manual revealed General Maintenance Instructions in Section 10 that stated: "To ensure smooth operation, the instrument is to be inspected by a qualified service engineer once a year for PM procedures." 2. Review of the laboratory's procedure manual revealed a policy that stated the cryostat "preventative maintenance will be performed each year". 3. Review of the laboratory's equipment maintenance records revealed no PM record in calendar year 2018. The inspector requested the documentation. The Clinical Director stated in an interview at approximately 11:30 AM, "we have Leica PM records for 2017 and 2019 but I am -- 2 of 3 -- unable to locate the 2018 documentation". 4. In an exit interview with the clinical and medical directors at 12:30 PM, the above listed findings were confirmed. -- 3 of 3 --